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Tommy Bax 🇬🇧 🇹🇼
@TommyBaxendale
·
4h
This list has been posted elsewhere before, but I felt in the lull period (read excruciating wait 😅) prior to the MHRA approval of DCVax-L it was prudent to make an update to keep in perspective the runway of potential catalysts that $NWBO have in store in the next ~18mths... 🧵
Tommy Bax 🇬🇧 🇹🇼
@TommyBaxendale
·
4h
To begin with, as a refresh of recent hurdles already achieved:
1) UK MHRA MAA submitted ✅ on 20th Dec with 'validation Passed' on 24th Jan & 'confirmation of Validation' 7th Mar via the MHRA's 150 Day Assessment, although it is contentious about when the clock actually begins!
Tommy Bax 🇬🇧 🇹🇼
@TommyBaxendale
·
4h
2) Flaskworks (FW) Update PR 6th Feb ✅. Prototype & optimisation phase completed. FW Unit supplier chosen. Build of GMP-grade units underway. Validation & qualification (equivalence testing) to be undertaken by Advent after 'several mths'. FW patent coverage even more extensive.
Tommy Bax 🇬🇧 🇹🇼
@TommyBaxendale
·
4h
3) Nature Communications publication of the DCVax + Poly-ICLC (NCT01204684) trial ✅. Results published 8th May 2024 here:
https://nature.com/articles/s41467-024-48073-y
Trial powered for biomarkers, but noted survival benefits are outstanding. Not just GBM but especially for Grade III Gliomas too.
From nature.com
Tommy Bax 🇬🇧 🇹🇼
@TommyBaxendale
·
4h
4) In terms of funding, NWBO secured another Fife loan from Streeterville Capital 26th Apr for $11m:
#dcvax $nwbo #gbm
— Peter Davis (@peter_brit) May 3, 2024
Judging by the company's recent loan statement, it looks like:
1. They believe they will be better funded to start payments at the end of THIS year
2. The agreement uses language including "pre-payment at any time" and "potential acceleration" again positive…
See new posts
Conversation
Tommy Bax 🇬🇧 🇹🇼
@TommyBaxendale
This list has been posted elsewhere before, but I felt in the lull period (read excruciating wait 😅) prior to the MHRA approval of DCVax-L it was prudent to make an update to keep in perspective the runway of potential catalysts that $NWBO have in store in the next ~18mths... 🧵
9:12 AM · Jun 13, 2024
·
1,103
Views
Tommy Bax 🇬🇧 🇹🇼
@TommyBaxendale
·
3h
To begin with, as a refresh of recent hurdles already achieved:
1) UK MHRA MAA submitted ✅ on 20th Dec with 'validation Passed' on 24th Jan & 'confirmation of Validation' 7th Mar via the MHRA's 150 Day Assessment, although it is contentious about when the clock actually begins!
Tommy Bax 🇬🇧 🇹🇼
@TommyBaxendale
·
3h
2) Flaskworks (FW) Update PR 6th Feb ✅. Prototype & optimisation phase completed. FW Unit supplier chosen. Build of GMP-grade units underway. Validation & qualification (equivalence testing) to be undertaken by Advent after 'several mths'. FW patent coverage even more extensive.
Tommy Bax 🇬🇧 🇹🇼
@TommyBaxendale
·
3h
3) Nature Communications publication of the DCVax + Poly-ICLC (NCT01204684) trial ✅. Results published 8th May 2024 here:
https://nature.com/articles/s41467-024-48073-y
Trial powered for biomarkers, but noted survival benefits are outstanding. Not just GBM but especially for Grade III Gliomas too.
From nature.com
Tommy Bax 🇬🇧 🇹🇼
@TommyBaxendale
·
3h
4) In terms of funding, NWBO secured another Fife loan from Streeterville Capital 26th Apr for $11m:
#dcvax $nwbo #gbm
— Peter Davis (@peter_brit) May 3, 2024
Judging by the company's recent loan statement, it looks like:
1. They believe they will be better funded to start payments at the end of THIS year
2. The agreement uses language including "pre-payment at any time" and "potential acceleration" again positive…
The Danish Dude
Re: Smitty5150 post# 698119
Thursday, June 13, 2024 7:10:43 AM
Post#
698122
of 698213
I disagree. Our situation can not be reduced to "having someone with biotech experience at the Helm".
Any long having dived into "the history" are aware of the spoofing having been done to NWBO since at least 2016. We have the Phase V Report. We have Woodford and FBI. We hae +40 hit pieces from AF. We have fraud lawsuits and complaints. We have threats directed at Linda Liau before TLD and Al Musella to get him remove information. We have multiple doctors to competitors that critizise the trial results while haven't disclosed their affiliations. We have had and still have a horde of paid shills doing Market Makers bidding on Ihub, InvestorsVillage, StockTwits, Yahoo, Benzinga, SeekingAlpha ... through many years trying to push sentiment towards negative, by distorting and manipulating facts. And we have had the honor of being first battling with immunotherapy experiences of pseudo-progression and trying to make out, whether regulators where at all inclined to deal with immunotherapy therapies, because their guidances where so yesteryear and not prepared for the use of trials with external control groups.
All that made NWBO having to finance the business at an extremely suppressed share price. Making decisions like stopping direct, making decisions to delay in order to let time work "for you" . And go quiet due to huge interest in taking any info which NWBO put out, and instigating fraud lawsuits and complaints on a manipulated version of that informations content.
So no, this has NOTHING to do with NOT having a management with biotech experience, because NWBO is only here today as well as retailers, because we had a CEO that managed to avoid all these obstacles and somehow secure milestone after milestone, while fudders on this board edited their "kick the can sheet" of when they predicted NWBO to be out of business.
Ohhh it's managements fault.
No its not. That is complete and utter bullshit, which one can only pretend to support, if one choses to live in a vacuum of the events that have preceded todays situation. That narrative is STRAIGHT out of a 101 FUD cheerleading textbook.
NWBO would've been sunk a long time ago, hadn't it been for Linda Powers. Anyone with shares left, have her to thank for that. No one would have managed to outsmart MM's from 2016 till now. Especially not a young energetic crew.
And that's why market makers are soon to be knee deep in shit.
ATL-DC is DCVax-L
Bright Boy
Re: TTsr post# 698108
Wednesday, June 12, 2024 11:38:08 PM
Post#
698116
of 698117
Great plan !Everything I've made trying to"Short Term" trade, you could easily put in a Piggy Bank. The companies I managed in the public arena were companies that I started from scratch and took them public when "Access To Capital" was a realistic possibility!!! A bit different today, when the MM's are allowed to transform somewhat fair and balanced market operations into HFT platforms that "Shave Points" on every "Start Up Game" in the global financial arena destroying innovation, that used to fuel our economy to new heights beyond our wildest imagination. Now the leaches patrol the centers for innovation, preying on the creative talents of others, by skimming and spoofing large percentages of their market caps that are critical to their growth and expansion, much the same way as what's happening to NWBO. NWBO has a slight advantage, because its product saves lives, the result of which pressures the politicians and ultimately the DOJ to intervene putting an end to these illegal marker manipulations.NWBO has the innovative, healthcare technologies in immunotherapies that is and will continue to revolutionize healthcare for decades to come!!!
Cheers,
BB
CrashOverride
Re: StonkMaster post# 697874
Wednesday, June 12, 2024 10:09:56 AM
Post#
697921
of 698077
NWBO shareholders are not in a world of hurt as they own the platform for all solid tumors! It's really interesting how you argue the approval process will take longer than expected then claim anyone who thinks that isn't the case will somehow lose conviction in the company which has JAMA, NATURE, Landmark PIII data, revolutionary manufacturing, and 60%+ survival for orphan cancer patients.
I am an eternal optimist because I see the monumental effort achieved by this management team which will save millions of lives. Why should I be pessimistic, pragmatic, or anything but elated when I own shares in a company that has achieved an elusive goal sought by thousands of scientists and business leaders over many decades?
Zero reason why this cost-effective nontoxic life-saving DCVax will not be approved. The company has resources to see us through the approval process. I believe we will have significant news before ASM. I do not think SIO would take an equity position now if approval would take until Fall.
However if approval takes until Fall I will not be in a world of hurt but well rested and tanned after enjoying a summer of relaxation.
After all management are doing the real work while I sit here on my couch arguing with anonymous posters on social media!
In the next few years many cancer patients will have the same outcome, able to rest beside the pool and argue how many more billions will be added to this company's market cap by the next quarter, thanks to the innovative Fordist manufacturing process known as Flaskworks which will bring autologous immunotherapies to the global masses.
This is something that every CAR-T company as well as even Gilead has failed to achieve. No manufacturing at scale exists for immunotherapies! So why would I ever be in a world of hurt owning shares in Northwest Biotherapeutics? Gilead are in a universe of pain because they don't own Northwest Biotherapeutics!
Folks, take the long-term perspective as we wait for MHRA approval!
Bullish
BULLISH
Do your own research. I am not providing legal or investment advice. Nothing I say should be considered solicitation to buy or sell any security. This is an anonymous forum for entertainment purposes only. Do not trust anything you read.Perk_Idaho
Re: evanstony post# 698063
Wednesday, June 12, 2024 6:14:20 PM
Post#
698069
of 698074
It's confusing, no doubt. I called my broker, he answered quickly and seemed well versed on the topic. Maybe he was wrong, I did run it through AI and got a similar answer. But I did not ask if the short seller actually sold the share to a buyer if the buyer would get the voting rights. So I don't know. It makes sense that you don't have voting rights if you lend out your shares, and it makes sense that the short seller would have the voting rights, but not if he sold the share and had not covered/returned the share. Once he covers, your voting rights would be restored.
From AI:
"If you lend your shares for short selling, you typically won't have voting rights while the shares are loaned out. The borrower, who is the short seller, becomes the temporary owner and has the voting rights. This is because the short seller is considered the registered holder of the shares on the record date, which is the date used to determine who is eligible to vote. Once you get your shares back from the borrower, you will regain voting rights."
hyperopia
Re: Pattyloco post# 670345
Wednesday, 02/07/2024 9:15:05 AM
I’ll break it down. The Flaskworks’ news is a VERY BIG DEAL, so don’t let the muted stock reaction fool you. The stock price is being suppressed by entities that are against Northwest Bio in order to create uncertainty and doubt about any positive news, with the idea being, that the news can’t be that important if the share price hardly increased. Nothing could be further from the truth.
In a nutshell, this Flaskworks news means that when Northwest Bio receives marketing approval, they will soon after, be able to produce their DCVax product to meet very strict commercial quality standards, in large quantities, at a low cost, and they will have patent protection from all the other competition that will come along and attempt to copycat Northwest Bio’s cell therapy. The biggest takeaway is that Northwest Bio has now industrialized the production process of a cell therapy, and they will be capable of producing tens of thousands of treatments annually, and eventually ramp up to hundreds of thousands as other solid-tumor indications are approved, and demand increases.
Due to the lack of any updates about the Flaskworks’ system for over a year, the haters have recently suggested that Flaskworks’ development has stalled, and that Northwest Bio is still years away from regulatory approval for an automated manufacturing system. They say that if and when Northwest Bio does receive marketing approval from regulators this year, they will have to produce the product using the very expensive, inferior manual process, which means they will only be able to produce hundreds of treatments annually, and they may not get insurance reimbursement because it will be too expensive to produce, or they won’t be able to earn much of a profit even if they do. This PR put all those ridiculous lies to death.
Since the Flaskworks acquisition in 2020, Northwest Bio (actually Flaskworks and Advent) has in fact, been very busy developing the original Flaskworks MicroDEN system, which was designed as a bench-top device intended for clinical trial production, which has lower regulatory requirements, and turning it into a commercial system with biosensors that are capable of providing real-time feedback on culturing conditions, and the ability to adjust those conditions as needed. This is necessary for commercial production, which has much higher regulatory requirements. The prototype culturing system was first revealed during a presentation entitled, Manufacturing of DCVax-L Past, Present and Future by Dr. Marnix Bosch, Chief Technical Officer of NW Bio, at ASCO on June 4, 2022. (better pictures here )
Yesterday’s Flaskworks press release revealed that in the time period since that ASCO presentation, Northwest Bio (Flaskworks and Advent) have actually further developed that commercial system, which was capable of producing one patient’s treatment (10-12 doses) at a time, into an industrial commercial system that is capable of producing 10-12 patient’s treatments (100-120 doses) at a time. This is A VERY BIG DEAL. With this Flaskworks automated process, Northwest Bio will be able to produce tens of thousands of treatments a year. All of the current companies with CAR-T cell therapy treatments are capable of producing a single patient’s treatment at a time, and are only able to produce a few thousand treatments a year. They are currently unable to meet patient demand, with long backlogs, and rationing care, which obviously limits the revenue they can earn.
So this Flaskworks news means that when the Flaskworks automated production process is approved, Northwest Bio will have the only commercial cell therapy treatment in the world that can produce enough treatments to meet a very high patient demand, which means this company will become much more valuable because the potential available revenue just skyrocketed. What this also means is that ten times the number of treatments can be manufactured from the same cleanroom footprint of that first iteration. As I said in another post a couple years ago, I think this may be what Michael Bigger was referring to as “cleanroom disruption.”
This brings up another interesting feature that was discussed in the press release; that the updated system now incorporates another previously separate process, in addition to cell culturing. As I’ve said in other posts, the manufacturing process has three main stages; the separation of the monocytes from the other white blood cells in the leukapheresis material, the culturing of those cells, and then filling the final product into individual dosage vials and cryopreserving. This new system now combines the first two steps in one system so that it not only requires less manufacturing systems, but it also allows those steps to be enclosed in one system so that it’s not necessary to transfer the cells from one machine to another, which saves time, reduces potential contamination, saves critical cleanroom space, and cuts down on expensive manpower.
Some have have speculated or at least hoped that the automated Flaskworks production process is a part of the marketing application, and it will also be approved when the DCVax product is approved. Linda Powers threw cold water on this idea at the shareholder meeting a year ago, but because the marketing application took so long to finish, some still thought that in that extra time, the development work on the Flaskworks system might also be finished. This PR dispelled this speculation, because it said that final installation, validation, and testing of the system will still need to be accomplished before it can be approved by the regulators, and the marketing application has already been submitted.
So the question that many may be asking is: “How long until it is approved by the regulators?”
First, I think it’s important to note that some of the development work that has already been completed was, “producing finished DCVax-L products with substantially the same composition and percentage purity of dendritic cells, the same biologic profile and functional characteristics of the cells, and the same yield in number of doses as with the existing manual process.” So Advent has already demonstrated to their own satisfaction that the Flaskworks’ system can produce an equivalent product as the current approved method. Now they just have to demonstrate it to the satisfaction of the regulators. They have also already engaged a contract manufacturer to make the systems that will be installed and validated at Sawston which may take a few months to receive. Then the validation - the Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), will take a few months. Then, a few side-by-side runs for the comparability study, and gather and assess the data, and submit the Comparability Protocol to the MHRA which could take a couple more months. The MHRA should be able to review the CP within a couple months, but possibly longer if there are still staffing issues. (the EMA has a 60-day response time for this type of filing, but I’m unsure about the MHRA) If all goes well, it may be possible to receive regulatory approval, and begin automated commercial production with Flaskworks by the end of the year.
So, in summation, THIS IS A VERY BIG DEAL!
LTR
Re: attilathehunt post# 698072
Wednesday, June 12, 2024 6:34:26 PM
Post#
698077
of 698077
Attila I think you are not correct here. Think about what happens in a short sale and I think you will conclude that the short does not ever hold a share and therefore he cannot vote. In a short sale, the trader borrows shares in order to sell shares. This is the opposite of the long position, where you buy the share and hold it for a period until you sell it. So the long trader in fact holds shares during that time. The short trader first sells shares, with the commitment to buy the shares at a future date. He cannot vote during the period between the sale of borrowed shares, and his buying of the shares later, because he does not actually own anything. At that future date when he buys the shares in order to complete the transaction, he does not own anything at the end of that transaction, because he already sold those shares up front. It's confusing and I really wish they do away with short selling all together. But this is how it stands and I fail to see any possibility here of the short holding shares that he can vote on.
maverick_1
Re: maverick_1 post# 697700
Tuesday, June 11, 2024 1:21:41 PM
Post#
697742
of 697779
Pertinent Chronological Adam Feuerstein posts! over 7 months vs Here-say DIVEL
Adam_Feuerstein
Re: maverick_1 post# 66345
Friday, July 08, 2016 7:23:15 AM
Post# of 697728
Who is AFraudstein?
He sounds like a very powerful, influential guy.
—————————————————————
Adam_Feuerstein
Re: beartrap12 post# 58581
Sunday, April 10, 2016 12:05:13 PM
Post# of 697730
I believe it was Flipper44 who claimed NWBO was negotiating a partnership with Merck and BMS for a DCVax-PD-1 combination trial.
He's wrong.
As I explained Friday, there is no partnership between the companies. There isn't even a collaboration.
UCLA wants to conduct a DCVax-PD-1 combination study. They're driving it. I spoke with Merck and BMS, they're not involved.
Maybe NWBO is collaborating with UCLA. If so, it's immaterial. PD-1s are commercially available. If NWBO and/or UCLA want to purchase PD-1s for use in a combination trial, they're free to do so. Thousands of combination studies involving cancer immunotherapies are being conducted today. The UCLA study just joins the crowd. No one cares.
Meantime, NWBO's ph3 study in frontline GBM remains halted. No progress has been made since August when patient enrollment was stopped. Promised follow-on studies with DCVax Direct haven't materialized. Promised revenue from compassionate use of DCVax-L in Germany hasn't materialized. NWBO has lost the support of its only institutional investor, forcing the company to raise money through distressed financings. The "internal" investigation results are delayed. The stock trades at an all-time low. Management remains silent.
But heck, you keep believing that everything is great.
——————————————————————-
Adam_Feuerstein
Re: sentiment_stocks post# 47962
Monday, December 21, 2015 2:04:09 PM
Post# of 697731
You could drive a Maverick_1 sized bus through the descriptions used by Linda to "update" investors (ahem) about enrollment in the ph3 trial. Meaningless.
———————————————————————————-
Adam_Feuerstein
Re: sentiment_stocks post# 47865
Sunday, December 20, 2015 8:13:43 PM
Post# of 697732
Asking Maverick_1 if he works for NWBO or is paid by NWBO to post here does not violate any of the "rules" you listed.
The financial conflicts of posters on this message board is certainly relevant to the investment thesis.
I'm asked a ton of questions here and I'm answering as many as I can. I've asked Maverick_1 one question but he's unwilling or afraid to answer.
—————————————————————————-
Adam_Feuerstein
Re: sentiment_stocks post# 47816
Sunday, December 20, 2015 2:24:39 PM
Post# of 697734
Does Mav calling me FRAUDSTEIN violate TOS rules?
Just wondering. I've been called worse.
——————————————————-
Adam_Feuerstein
Re: None
Sunday, December 20, 2015 2:16:30 PM
Post# of 697735
New theory: Maverick_1 is Larry Smith.
What do you think?
—————————————————
Adam_Feuerstein
Re: None
Saturday, December 19, 2015 10:40:30 PM
Post# of 697736
What is Maverick_1 afraid of?
Every time I ask him a question on this board, my post is deleted.
All I want to know is if Maverick_1 is an employee of NWBO or otherwise paid by the company to post on this message board. I ask him, he doesn't respond and then my post is deleted.
The TOS rules don't appear to be applied equally on this message board, because Maverick_1's numerous off-topic and disparaging posts about me are never deleted.
Why is Maverick_1 so afraid to answer my questions?
———————————————————————————
Adam_Feuerstein
Re: maverick_1 post# 47485
Friday, December 18, 2015 6:24:27 AM
Post# of 697738
Does Maverick_1 work for NWBO?
Why won't he answer my question? Is he paid by the company to post here?
Who is he? I'm not afraid to identify myself. Why does Maverick_1 hide behind an alias?
————————————————————
AND AFeuerstein FIRST POST a DOZZY
Adam_Feuerstein
Re: PacificNW post# 47288
Wednesday, December 16, 2015 9:54:52 PM
Post# of 697739
I'm sure you already know I don't believe in any of the cancer vaccine technology NWBO is developing. DCVax L and Direct will surely fail and never be approved. There's no reason to believe otherwise. All the Linda Powers/Cognate self-enrichment stuff is fun, but the fundamental bear thesis against NWBO is based on the impotence of the DCVax platform.
It's late. I'll get into details later.
G'night.
—————————————————————-
I finally relented and posted a reply to A Feuerstein re ALL of the above:
I have NO NWBO AFFILIATION nor do I receive any compensation for posting!
UNLIKE the ballooning brigade for the DARK Forces.
DIFFERENT STROKES for DIFFERENT FOLKS
Northwest Biotherapeutics gets grant for cell culture system with symmetrical fluid flow channels
Brought to you by GlobalData
Share
Northwest Biotherapeutics has been granted a patent for a cell culture cartridge designed to provide symmetrical fluid flow and avoid dead areas within the chamber. The system includes multiple inlets and a shared outlet for efficient cell culture processes. GlobalData’s report on Northwest Biotherapeutics gives a 360-degree view of the company including its patenting strategy. Buy the report here.
According to GlobalData’s company profile on Northwest Biotherapeutics, Personalized cancer vaccines was a key innovation area identified from patents. Northwest Biotherapeutics's grant share as of April 2024 was 32%. Grant share is based on the ratio of number of grants to total number of patents.
Cell culture system with symmetrical fluid flow channels
Source: United States Patent and Trademark Office (USPTO). Credit: Northwest Biotherapeutics Inc
See Also:
FDA gives accelerated approval for Ipsen's Iqirvo for primary biliary cholangitis
Risk adjusted net present value: What is the current valuation of F. Hoffmann-La Roche's Dirloctocogene Samoparvovec?
A recently granted patent (Publication Number: US11952563B2) discloses a cell culture system designed to optimize fluid flow and avoid dead areas within the cell culture chamber. The system includes a cell culture cartridge with symmetrical fluid flow channels and a computer system with control systems and programs for managing the flow of fluids within the system. Additionally, pumps are connected to the central processing unit to provide unidirectional or counter-current flow, while sensors monitor and adjust parameters such as medium flow rate and cytokine concentration.
Furthermore, the cell culture system incorporates features for optimizing cell culture conditions, such as calculating perfusion rates to maximize cell contact, and utilizing an objective function to optimize operational constraints. The system also includes modifications to the bottom surface of the cell culture chamber to facilitate cell adhesion, along with sample tracking components, outlets, inlets, medium reservoirs, waste reservoirs, and Luer Activated Valves for sterile bidirectional flow. Overall, the patented system aims to enhance the efficiency and effectiveness of cell culture processes by ensuring optimal fluid dynamics and control over various parameters critical for cell growth and product characteristics.
To know more about GlobalData’s detailed insights on Northwest Biotherapeutics, buy the report here.
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Blending expert knowledge with cutting-edge technology, GlobalData’s unrivalled proprietary data will enable you to decode what’s happening in your market. You can make better informed decisions and gain a future-proof advantage over your competitors.
Be better informed
GlobalData
GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.
GlobalData Patent Analytics tracks bibliographic data, legal events data, point in time patent ownerships, and backward and forward citations from global patenting offices. Textual analysis and official patent classifications are used to group patents into key thematic areas and link them to specific companies
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Northwest Biotherapeutics Inc - Company Profile
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Northwest Biotherapeutics gets grant for cell culture system with symmetrical fluid flow channels
Brought to you by GlobalData
Share
Northwest Biotherapeutics has been granted a patent for a cell culture cartridge designed to provide symmetrical fluid flow and avoid dead areas within the chamber. The system includes multiple inlets and a shared outlet for efficient cell culture processes. GlobalData’s report on Northwest Biotherapeutics gives a 360-degree view of the company including its patenting strategy. Buy the report here.
According to GlobalData’s company profile on Northwest Biotherapeutics, Personalized cancer vaccines was a key innovation area identified from patents. Northwest Biotherapeutics's grant share as of April 2024 was 32%. Grant share is based on the ratio of number of grants to total number of patents.
Cell culture system with symmetrical fluid flow channels
Source: United States Patent and Trademark Office (USPTO). Credit: Northwest Biotherapeutics Inc
See Also:
FDA gives accelerated approval for Ipsen's Iqirvo for primary biliary cholangitis
Risk adjusted net present value: What is the current valuation of F. Hoffmann-La Roche's Dirloctocogene Samoparvovec?
A recently granted patent (Publication Number: US11952563B2) discloses a cell culture system designed to optimize fluid flow and avoid dead areas within the cell culture chamber. The system includes a cell culture cartridge with symmetrical fluid flow channels and a computer system with control systems and programs for managing the flow of fluids within the system. Additionally, pumps are connected to the central processing unit to provide unidirectional or counter-current flow, while sensors monitor and adjust parameters such as medium flow rate and cytokine concentration.
Furthermore, the cell culture system incorporates features for optimizing cell culture conditions, such as calculating perfusion rates to maximize cell contact, and utilizing an objective function to optimize operational constraints. The system also includes modifications to the bottom surface of the cell culture chamber to facilitate cell adhesion, along with sample tracking components, outlets, inlets, medium reservoirs, waste reservoirs, and Luer Activated Valves for sterile bidirectional flow. Overall, the patented system aims to enhance the efficiency and effectiveness of cell culture processes by ensuring optimal fluid dynamics and control over various parameters critical for cell growth and product characteristics.
To know more about GlobalData’s detailed insights on Northwest Biotherapeutics, buy the report here.
Premium Insights
From
The gold standard of business intelligence.
Blending expert knowledge with cutting-edge technology, GlobalData’s unrivalled proprietary data will enable you to decode what’s happening in your market. You can make better informed decisions and gain a future-proof advantage over your competitors.
Be better informed
GlobalData
GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.
GlobalData Patent Analytics tracks bibliographic data, legal events data, point in time patent ownerships, and backward and forward citations from global patenting offices. Textual analysis and official patent classifications are used to group patents into key thematic areas and link them to specific companies
Share
Smarter leaders trust GlobalData
Report-cover
Data Insights
Northwest Biotherapeutics Inc - Company Profile
Buy the Report
Data Insights
The gold standard of business intelligence.
Find out more
Related Company Profiles
Northwest Biotherapeutics Inc
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I strongly believe that it is in the interest of all NWBO shareholders to vote "FOR" management . If you have time, reread Bright Boy's recent postings .
Bright Boy
Re: S_mack post# 697488
Monday, June 10, 2024 6:47:11 PM
Post#
697533
of 697746
I/We/Management, I'm guessimg are frustrated that the entire process is not more under company control, but rejecting outside interest doesn't make sense. I spent 3 years with a PR group that was probably the most effective global outlet in history and the leadership would always remind us that the important thing was "Recognition" whether by name or event, because 99.9% of the people that hear or see a headline will not remember 99.9% of the content 2 hours after seeing/hearing it unless it directly effects their personal, financial condition. So for the Big Biz show to shout out NWBO loud and clear will at least start the process of Name Identification, which will be a lot more than we had the day before.
Also, all the chatter about voting NO is ridiculous. All most people want is a higher SP and voting NO will hurt the company and the SP and help Griffin and the MM's in their efforts to destroy our company. I can assure you that management is doing everything in their power to defeat the manipulators and I'm confident will win the battle. Our new institutional investor, SIO certainly thinks so and like all NWBO shareholders have put their money where their mouth is!
Cheers,
BB
Bright Boy
Re: S_mack post# 697428
Monday, June 10, 2024 3:45:34 PM
Post#
697462
of 697747
So people that can only afford to invest in lower cost stocks are not worthy of NWBO's attention and information? You obviously consider them to be BENEATH your level of attention!!! Does that also mean if you were introduced to them in public/socially that you would not speak to them??WTF are you??
How about all the cancer patients that have spent most of their money on wildly expensive treatments that don''t work very well , providing record profits to the very Big Biotech companies that are hoping to slow NWBO's approval process?? Do those people not deserve to be able to make small investments in companies that might provide a better treatment for their illness???
I guess you would consider this group of investors to fall into the category of "UNDESIRABLES" !!!
Cheers,
BB
Bright Boy
Re: attilathehunt post# 697105
Saturday, June 08, 2024 10:23:21 PM
Post#
697108
of 697747
Why would anyone vote to deprive management of their compensation. They have devoted 13 years of their lives to bring this incredible cancer treatment to patients! Hell, the compensation packages are underwater and will only amount to something at much higher SP's. Management has not sold a single share as compared to the totally disgusting NVCR's management that has sold hundreds of millions of dollars worth of stock!!! Every biotech exec that I've talked to has told me that NWBO's management team consists of miracle workers. So do the right thing. VOTE YES and tell the "Activist Court" and Ken Griffin to go straight to Hell !!!
This is our company not theirs AND we are proud of what our management team has accomplished against all odds!!!
Cheers,
Bright Boy
Re: attilathehunt post# 697105
Saturday, June 08, 2024 10:23:21 PM
Post#
697108
of 697747
Why would anyone vote to deprive management of their compensation. They have devoted 13 years of their lives to bring this incredible cancer treatment to patients! Hell, the compensation packages are underwater and will only amount to something at much higher SP's. Management has not sold a single share as compared to the totally disgusting NVCR's management that has sold hundreds of millions of dollars worth of stock!!! Every biotech exec that I've talked to has told me that NWBO's management team consists of miracle workers. So do the right thing. VOTE YES and tell the "Activist Court" and Ken Griffin to go straight to Hell !!!
This is our company not theirs AND we are proud of what our management team has accomplished against all odds!!!
Cheers,
BB
Problem: how many days after the March 7th validation will the MAA be approved?https://t.co/HTUCYJmI6N @https://x.com/alphavestcap/status/1800289007089401950https://t.co/kg1tQf8xEB https://t.co/8qDBtJofYs
— alphavestcapital.com (@alphavestcap) June 10, 2024
$nwbo @alphavestcap
— alphavestcapital.com (@alphavestcap) June 10, 2024
Just like the unknown MAA approval date, the components of the next $nwbo combo trail are unknown.https://t.co/5COCD6V0VIhttps://t.co/HTUCYJmI6N https://t.co/MTNivDY7v2 https://t.co/8qDBtJofYs
https://www.gov.uk/guidance/guidance-on-150-day-assessment-for-national-applications-for-medicines
So where does this 3/7/24 validation put the date of final maa approval?
$NWBO @hoffmann6383 Unless I am reading the reply from MHRA wrong, it appears I owe you a beer as validation likely began on March 7th. pic.twitter.com/GdsdIa6zPU
— Cesar Urrea (@Tijero) June 10, 2024
So where does this 3/7/24 validation put the date of final maa approval?
Sure. See my Tweet above or the attached image with my question to the MHRA. pic.twitter.com/VwRggWkrrX
— Cesar Urrea (@Tijero) June 10, 2024
dstock07734: Does SIO disclose in sec filings and/or on its website all its public and private holdings ? I have not found them. A scientific advisor to alphavestcapital.com has suggested that SIO might have a strong working knowledge dendritic cell cancer vaccines from another dendrtitic cell company. jhpratt@alphavestcapital.com .A.E.K.
Re: theorysuit post# 697293
Sunday, June 09, 2024 11:53:39 PM
Post#
697310
of 697319
We don't need to wait for SIO's filings in mid-August. I can tell you now.
The board has been talking about the significance of SIO investment. What I am really curious about is what could possibly bring SIO to NWBO. I read the dissertation of the researcher in SIO, the only one who has the Ph.D. in in Molecular and Cellular Pharmacology. The gentle man is an expert in the field of small molecule inhibitor related to the modulation of t-cell function which may explain why SIO recently opened a position in Tyra in the past first quarter, a company trying to develop small molecule drugs, like FGFR inhibitor. Is it possible that when he was doing DD on Tyra and reading peer-reviewed publications on FGFR and its inhibitors he bumped into DCVax-L?
For instance, papers like the following which mentioned about both DCVax-L and FGFR. I think the answer is highly possible.
https://pubmed.ncbi.nlm.nih.gov/31106606/
https://www.spandidos-publications.com/10.3892/ol.2022.13632
https://www.mdpi.com/1422-0067/23/10/5351
https://www.mdpi.com/2072-6694/15/17/4279
Do you still think SIO is not a serious player? I can guarantee you SIO is a very serious player. Every share they are buying now will turn into a gold bar later.
Here is something from ChatGPT on FGFR inhibitor. You may read it for fun.
FGFR inhibitors can help overcome immunosuppression in the tumor microenvironment and enhance anti-tumor immunity through several mechanisms:
Reduction of Tumor Cell Proliferation and Survival: By inhibiting FGFR signaling, FGFR inhibitors can reduce the proliferation and survival of cancer cells, making them more susceptible to immune cell-mediated killing. This can decrease the overall tumor burden and potentially expose more tumor antigens to the immune system.
Modulation of Cytokine Production: FGFR inhibitors can alter the production of cytokines and growth factors within the tumor microenvironment. This can lead to a reduction in immunosuppressive cytokines (like TGF-ß and IL-10) and an increase in pro-inflammatory cytokines that promote immune cell activation and infiltration.
Reduction of Immunosuppressive Cell Recruitment: By disrupting FGFR signaling, FGFR inhibitors can decrease the recruitment and activity of immunosuppressive cells such as regulatory T cells (Tregs) and myeloid-derived suppressor cells (MDSCs) within the tumor microenvironment. This reduction can relieve immune suppression and enhance the anti-tumor activity of effector immune cells.
Enhanced Immune Cell Infiltration: FGFR inhibition can lead to changes in the tumor vasculature and extracellular matrix, improving the infiltration of immune cells into the tumor. This increased infiltration can boost the effectiveness of the immune response against the tumor.
Synergistic Effects with Immunotherapy: FGFR inhibitors can be combined with immune checkpoint inhibitors (such as anti-PD-1/PD-L1 or anti-CTLA-4 antibodies) to enhance their efficacy. By reducing the immunosuppressive environment, FGFR inhibitors can improve the responsiveness of tumors to immunotherapy, leading to better clinical outcomes.
Downregulation of Immune Checkpoint Molecules: FGFR inhibitors can decrease the expression of immune checkpoint molecules like PD-L1 on tumor cells, making them more susceptible to immune attack. This can enhance the effectiveness of immune checkpoint blockade therapies.
Overall, by targeting the FGFR pathway, FGFR inhibitors can help remodel the tumor microenvironment to be more conducive to an effective anti-tumor immune response, thereby overcoming immunosuppression and improving the efficacy of cancer treatments.
Professor Murakami Explains the Mechanism of Turbo Cancers 💉☠️
— “Sudden And Unexpected” (@toobaffled) June 9, 2024
Professor Emeritus Yasufumi Murakami of Tokyo University of Science: "It is almost certain that vaccines are contaminated with DNA. mRNA vaccines containing the DNA causes turbo cancers." pic.twitter.com/8cEflVngWC
dstock07734
Re: Horseb4CarT post# 697125
Sunday, June 09, 2024 2:48:00 PM
Post#
697220
of 697238
Horse,
Here is the clinical trial on prostate cancer with Oncovir as collaborator. The trial was done and the results have been reported. Here is the title of the trial. Horse, I think you would agree that this intratumoral administration of poly-iclc can be combined with the Direct right away in the prospective trials.
Phase I Study of In Situ Autologous Vaccination Against Prostate Cancer With Intratumoral and Systemic Hiltonol® (Poly-ICLC) Prior To Radical Prostatectomy
https://clinicaltrials.gov/study/NCT03262103
The reason I was talking about HIV as a target in the future trials is that there were clinical trials on HIV using the product CYT107 from the company called RevImmune solely owned by LP and the results were published. We can also see Oncovir and RevImmune are actively involved in the funded project in France which is about infectious diseases.
Randomized Study on Multiple Cycles of Interleukin-7 in HIV Patients Immune Non-responders (Inspire 3)
https://clinicaltrials.gov/study/NCT01241643
Study on Interleukin-7 (CYT107) in HIV Patients (Inspire 2)
https://clinicaltrials.gov/study/NCT01190111
Repeated Cycles of Recombinant Human Interleukin 7 in HIV-Infected Patients With Low CD4 T-Cell Reconstitution on Antiretroviral Therapy: Results of 2 Phase II Multicenter Studies
https://academic.oup.com/cid/article/62/9/1178/1745261
A platform of vaccine candidates has been developed within VRI (Lipopeptides, DC based vaccines, Pox virus (MVA)) or in collaboration: NYVAC (CHUV, Eurovacc, Sanofi Pasteur), DNA (Eurovacc, Fit Biotech), new flavivirus (Replivax vector Sanofi Pasteur), Ad26/MVA Ebola (Janssen), VSV Ebola (Merck) & adjuvant/immunomodulators: Poly-ICLC (Oncovir), GLA (AAHI), IL-7 (Cytheris, Revimmune). In the last twelve years, several HIV programs have been moved from preclinical to phase I/II clinical trials (Light, VRI01&06, EHVAP01).
https://anr.fr/en/funded-projects-and-impact/funded-projects/project/funded/invest/b2d9d3668f92a3b9fbbf7866072501ef-10d51590a1/?tx_anrprojects_funded%5Bcontroller%5D=Funded&cHash=53a0b931f6aa034ba6783a05406ce505
beartrap12
Re: hyperopia post# 697194
Sunday, June 09, 2024 3:19:16 PM
Post#
697225
of 697238
Thank you, hyperopia, for finding this explanation of the differences between Dr. Liau's 3-month acid-eluded method and Dr. Bosch's 8-day lysate method of making our vaccine.
Here is what Dr. Bosch was trying to explain to me in 2015 when I talked to him at a conference and I just didn't understand it: Hs method...
* Avoids need for long-term culture as lysate can be generated directly from surgically resected tissue
And thanks for reminding me what the term was for Dr. Liau's method: acid-eluded peptides.
Bullish
BULLISHhyperopia
Re: beartrap12 post# 696941
Sunday, June 09, 2024 11:40:30 AM
Post#
697194
of 697237
Right, Dr. Bosch has discussed optimizing UCLA’s manufacturing process, that was used in Dr. Liau’s phase I trial, numerous times. In fact, there’s still a link to one of these presentations on NW Bio’s website, from the first Glioblastoma Drug Development Summit in 2019; slides 4 & 5:
First Clinical Trial
Dendritic Cell Vaccination in Glioblastoma Patients Induces Systemic and Intracranial T-cell Responses Modulated by the Local Central Nervous System Tumor Microenvironment
Autologous dendritic cells were pulsed with acid-eluted peptides from cultured autologous GBM cells to stimulate a class I – restricted CTL response
Survival data from this trial are highly encouraging
Linda Liau et al., Clin. Cancer Res. 11: 5552. 2005
Process Optimization
Initial assessment identified GBM as an interesting target but raised questions about scale-up of acid elution of cultured GBM cells
* Culture of autologous GBM cells often requires months of culture time to obtain sufficient numbers of cells
* Acid-elution process proved difficult to standardize
* Acid-elution resulted in cell death and release of a range of molecular species, varying in mass from small peptides to large macromolecules, with no identifiable peak at 9 amino acids
Use of tumor cell lysates developed as an alternative
* Avoids need for long-term culture as lysate can be generated directly from surgically resected tissue
* Range of molecular species is similar to acid-eluted material
NWBO
Re: Hopeforthefuture3 post# 696891
Saturday, June 08, 2024 7:34:38 AM
Post#
696941
of 697237
Hope, you are right that UCLA developed the original DCVax-Brain that was used in the first clinical trial Phase 1, but NWBO and Dr. Bosch turned it into a commercial product. UCLA's original product took 3 months to make, while Dr. Bosch came up with a way to create lysate from the tumor in 8 days. NWBO's version went through a second Phase 1, successfully duplicating UCLA's Dr. Liau's results. I got this from Dr. Bosch at a conference in 2015.
Bullish
BULLISH
dstock07734
Re: Horseb4CarT post# 697125
Sunday, June 09, 2024 2:48:00 PM
Post#
697220
of 697237
Horse,
Here is the clinical trial on prostate cancer with Oncovir as collaborator. The trial was done and the results have been reported. Here is the title of the trial. Horse, I think you would agree that this intratumoral administration of poly-iclc can be combined with the Direct right away in the prospective trials.
Phase I Study of In Situ Autologous Vaccination Against Prostate Cancer With Intratumoral and Systemic Hiltonol® (Poly-ICLC) Prior To Radical Prostatectomy
https://clinicaltrials.gov/study/NCT03262103
The reason I was talking about HIV as a target in the future trials is that there were clinical trials on HIV using the product CYT107 from the company called RevImmune solely owned by LP and the results were published. We can also see Oncovir and RevImmune are actively involved in the funded project in France which is about infectious diseases.
Randomized Study on Multiple Cycles of Interleukin-7 in HIV Patients Immune Non-responders (Inspire 3)
https://clinicaltrials.gov/study/NCT01241643
Study on Interleukin-7 (CYT107) in HIV Patients (Inspire 2)
https://clinicaltrials.gov/study/NCT01190111
Repeated Cycles of Recombinant Human Interleukin 7 in HIV-Infected Patients With Low CD4 T-Cell Reconstitution on Antiretroviral Therapy: Results of 2 Phase II Multicenter Studies
https://academic.oup.com/cid/article/62/9/1178/1745261
A platform of vaccine candidates has been developed within VRI (Lipopeptides, DC based vaccines, Pox virus (MVA)) or in collaboration: NYVAC (CHUV, Eurovacc, Sanofi Pasteur), DNA (Eurovacc, Fit Biotech), new flavivirus (Replivax vector Sanofi Pasteur), Ad26/MVA Ebola (Janssen), VSV Ebola (Merck) & adjuvant/immunomodulators: Poly-ICLC (Oncovir), GLA (AAHI), IL-7 (Cytheris, Revimmune). In the last twelve years, several HIV programs have been moved from preclinical to phase I/II clinical trials (Light, VRI01&06, EHVAP01).
https://anr.fr/en/funded-projects-and-impact/funded-projects/project/funded/invest/b2d9d3668f92a3b9fbbf7866072501ef-10d51590a1/?tx_anrprojects_funded%5Bcontroller%5D=Funded&cHash=53a0b931f6aa034ba6783a05406ce505
dstock07734
Re: newman2021 post# 696984
Saturday, June 08, 2024 12:48:41 PM
Post#
697004
of 697237
Has the human immune system been evolving over millions of years? Who knows our immune system better than the commander of human immune system, the dendritic cells?
I strongly suggest every NWBO longs should download the data Dr.Liau uploaded. There are over thirty thousand genes. All those overexpressed ones have significant changes after the administration of DCVax-L plus poly-iclc.
Now I think I know why all the BPs are hiring people with expertise on computational biology like crazy.
https://www.ncbi.nlm.nih.gov/geo/query/acc.cgi?acc=GSE237562
As for BO, I really don't think there will be one. The reason is simple. Merck cannot afford it. We can use Prometheus as an illustration. Merck paid half of the market cap of two rare diseases. The market cap for solid tumors could be $300b. Can Merck pay $150b? I haven't included infectious diseases, autoimmune diseases, antifungal field and I haven't included the possibilities on all the mammals. Oh, I haven't included the value of newly found peptides from the DCVax-L platform which can be used for neo-peptide vaccine.
There must be a reason that UCLA is ambitious to build a bio Silicon Valley!
https://s21.q4cdn.com/488056881/files/doc_presentations/2023/04/Splash-Investor-Event-Slides-FINAL-1.pdf
dstock07734
Re: beartrap12 post# 696941
Saturday, June 08, 2024 11:34:01 AM
Post#
696987
of 697236
beartrap,
No need to spend time on this. All in all NWBO has the sole ownership of most patents related to DCVax-L. The current combo trial is using the technology licensed from NWBO.
There is something we should be curious about.
See this analysis on the tissue samples from the p3 trial which was done by NCI scientists and Dr. Liau with no NWBO employees involved. Ask yourself why Dr.Bosch was not among the coauthors.
https://www.ncbi.nlm.nih.gov/geo/query/acc.cgi?acc=GSE249282
Then take a look at the combo trial. The same question: why NWBO is not among the collaborators?
https://clinicaltrials.gov/study/NCT04201873
Both have NCI involved, both are related to DCVax-L and yet NWBO didn't show up in both.
https://clinicaltrials.gov/study/NCT02834013
beartrap,
No need to spend time on this. All in all NWBO has the sole ownership of most patents related to DCVax-L. The current combo trial is using the technology licensed from NWBO.
See this analysis on the tissue samples from the p3 trial which was done by NCI scientists and Dr. Liau with no NWBO employees involved. Ask yourself why Dr.Bosch was not among the coauthors.
https://www.ncbi.nlm.nih.gov/geo/query/acc.cgi?acc=GSE249282
Then take a look at the combo trial. The same question: why NWBO is not among the collaborators?
https://clinicaltrials.gov/study/NCT04201873
Both have NCI involved, both are related to DCVax-L and yet NWBO didn't show up in both. Why is that?
Note that NCI knows very well about DCVax-L since it has been funding Dr.Liau over the past many years. Here is a clinical trial initiated in January 2017 and run by NCI. It has 94 types of rare cancers. Guess what? GBM was not included.
https://clinicaltrials.gov/study/NCT02834013
dstock07734
Re: newman2021 post# 696984
Saturday, June 08, 2024 12:48:41 PM
Post#
697004
of 697143
Has the human immune system been evolving over millions of years? Who knows our immune system better than the commander of human immune system, the dendritic cells?
beartrap12
Re: Horseb4CarT post# 697125
Sunday, June 09, 2024 7:39:36 AM
Post#
697137
of 697144
Horse, this is the wonder of Linda's decision to take the company into the franchise business: Any bio company can come to NWBO and partner with us to find a cure for anything, including fungus, viruses, autoimmune, etc. They can add DCVax, in either form, L or Direct (once it's approved), and design and run the clinical trial, and pay us for our contribution. NWBO, with Dr. Liau on our scientific board, can continue to advance the knowledge of dendritic cells and expand DCVax's uses on its own, if it wants to.
Tremendous decision on management's part. Let's continue to pay them well!
Bullish
BULLISH
I strongly suggest every NWBO longs should download the data Dr.Liau uploaded. There are over thirty thousand genes. All those overexpressed ones have significant changes after the administration of DCVax-L plus poly-iclc.
Now I think I know why all the BPs are hiring people with expertise on computational biology like crazy.
https://www.ncbi.nlm.nih.gov/geo/query/acc.cgi?acc=GSE237562
As for BO, I really don't think there will be one. The reason is simple. Merck cannot afford it. We can use Prometheus as an illustration. Merck paid half of the market cap of two rare diseases. The market cap for solid tumors could be $300b. Can Merck pay $150b? I haven't included infectious diseases, autoimmune diseases, antifungal field and I haven't included the possibilities on all the mammals. Oh, I haven't included the value of newly found peptides from the DCVax-L platform which can be used for neo-peptide vaccine.
There must be a reason that UCLA is ambitious to build a bio Silicon Valley!
https://s21.q4cdn.com/488056881/files/doc_presentations/2023/04/Splash-Investor-Event-Slides-FINAL-1.pdf
beartrap12
Re: sentiment_stocks post# 697124
Sunday, June 09, 2024 7:18:52 AM
Post#
697132
of 697146
Yes, Senti. UCLA conducted the second P1 with Dr. Bosch's change to manufacturing and when they got the same results, NWBO purchased DCVax from UCLA. Without NWBO's contribution, Dr. Liau's invention would probably have sat on a shelf unless she came up with a remedy to the 3 months it took to create the vaccine. Quick manufacturing was the key to marketing on a large scale. Dr. Bosch took it down from 3 months to 8 days. It was around 2002 and the trial was for 2 years, I believe.
Bullish
Single Stock
Re: skitahoe post# 697048
Sunday, June 09, 2024 4:47:29 AM
Post#
697127
of 697146
Companies that voluntarily delist from Nasdaq can relist at minimum PPS of just $2 following 5 consecutive closes above $2.
@andrewcaravello
$NWBO #DCVAX #Flaskworks ChatGpt:
Northwest Biotherapeutics (NWBO) has been successful in securing patents for its technologies in various regions, including the Philippines. They have received patents related to their DCVax® personalized immune therapies and their Flaskworks manufacturing system. These patents were granted in early 2024, covering innovations in dendritic cell compositions and immunotherapeutic treatments for advanced cancers [oai_citation:1,NorthWest Biotherapeutics Inc (NWBO): in-license of poly iclc patents would...](https://investorshub.advfn.com/boards/read_msg.aspx?message_id=174399977) [oai_citation:2,NorthWest Biotherapeutics Inc (NWBO): This patent, being granted in February 2...](https://investorshub.advfn.com/boards/read_msg.aspx?message_id=173876931) [oai_citation:3,NorthWest Biotherapeutics Inc (NWBO): $NWBO patent granted on March 27, 2024 -...](https://investorshub.advfn.com/boards/read_msg.aspx?message_id=174124152) [oai_citation:4,NorthWest Biotherapeutics Inc (NWBO): $NWBO patent granted on January 31, 2024...](https://investorshub.advfn.com/boards/read_msg.aspx?message_id=173739090).
If my calls for $NWBO for Philippine oncology is correct, then I'm the next Keith Gill of Asia, and I'm already way ahead of the distributors & investors shooting their shot for any cancer treatment.
I already have the economic research. Just a matter of time.
dstock07734
Re: pqr post# 696465
Thursday, June 06, 2024 12:00:21 AM
Post#
696466
of 696671
Both Keytruda and Opdivo hit patent cliffs in 2028. Time is running out for Merck and BMS.
https://www.proclinical.com/blogs/2024-2/top-10-drugs-with-patents-due-to-expire-in-the-next-5-years
dstock07734
Re: pqr post# 696465
Thursday, June 06, 2024 12:00:21 AM
Post#
696466
of 696672
Both Keytruda and Opdivo hit patent cliffs in 2028. Time is running out for Merck and BMS.
https://www.proclinical.com/blogs/2024-2/top-10-drugs-with-patents-due-to-expire-in-the-next-5-years
Re: dstock07734 post# 696609
Thursday, June 06, 2024 7:42:54 PM
Post#
696659
of 696672
Dstock, Agree it is very possible. Potentially the weakness in the Merck and Moderna combo therapy strategy is that neither of them work on cold tumor environments and together would only increase toxicity levels. Just my thinking, not an expert.
On hot tumor environments, checkpoint inhibitors and mRNA work because their MOAs depend on having T cells already at the tumor site. Cold tumor environments would not or have very little.
On toxicity, mRNA produces a predefined single antigen, and similar to ADCs, the same protein might be present in healthy tissue and organs, ie toxicity. Add that CI’s take the brakes off of the T cell response and it seems we would get an increase in the combined risk profile.
To me a combo strategy works best if one drug compensates for the other's weakness. I don’t see that synergy in a Merck and Moderna combo.
On the other hand, the DCVax technology platform makes it a perfect candidate for combo therapy. It brings T cells, B cells and antigens into cold and hot tumor environments and does not add toxicity.
Bullish
dstock07734
Re: Chiugray post# 696470
Thursday, June 06, 2024 3:41:19 PM
Post#
696609
of 696672
Thanks for the reply.
I found it was really interesting. All the targets in the collaboration trials between Merck and Moderna fall into the category of 'hot tumor'. I suspect they don't have confidence in giving 'cold tumor' a shot.
But Merck is one of the collaborators in a clinical trial on the toughest target which is using the technology licensed by NWBO. Sorry Moderna. Sooner or later, Merck will cut you loose just what happened to Seagen after spending $1.6b.
clinicaltrials.gov/study/NCT03897881
https://classic.clinicaltrials.gov/ct2/show/NCT05933577
https://clinicaltrials.gov/study/NCT06077760
https://classic.clinicaltrials.gov/ct2/show/NCT06295809
https://clinicaltrials.gov/study/NCT06305767
https://clinicaltrials.gov/study/NCT06307431
Until this Joseph Gunnar client(
) made this investment(https://www.sec.gov/ix?doc=/Archives/edgar/data/1072379/000110465924068314/tm2416435d1_8k.htm) , NWBO's door to institutional ownwership had been closed. There's now a crack(This direct investment by SIO Capital Management to purchase 8,125,000 shares of $NWBO IMO means that SIO Capital, with $1.4 billion AUM, will protect their investment by ensuring that NWBO has enough capital & working capital through #DCVax-L approvals in the UK, then US,… pic.twitter.com/tyrZr20Azn
— ATLnsider (@ATLnsider) June 5, 2024
) , but the door will not be fully opened until $nwbo has been uplisted from the den of iniquity. Joseph Gunnar is a class act in the micro and small cap sector of the American stock market. Just look at their 35 pages of transactions (https://www.instagram.com/jgunnarofficial/) . If $nwbo can hit its business development targets in the next 90 days(https://bamboolounge.substack.com/p/sio-capital-buys-into-nwbo?r=1tgwv) , maybe the pre IPO returns of FB and TWTR that Joseph Gunnar created can be repeated(SIO closed 6/5/24 $nwbo @alphavestcap @ATLnsider @metacollectiveG @BrianEgolf2 @hoffmann6383
— alphavestcapital.com (@alphavestcap) June 6, 2024
"Sio is an institution with $900m in AUM. This is an institution with only 42 long positions. In fact, Sio has historically held moderately larger short positions than long positions.… https://t.co/tOAW8GU7Zs
).https://t.co/FbxMY9EDkX $nwbo @alphavestcap https://t.co/4quCQ0ebKx
— alphavestcapital.com (@alphavestcap) June 6, 2024
(dave -35 pages of Joseph Gunnar transactions. Before FB and TWTR went public , they raised $450 million for them. AUM $1.4 billion.) https://t.co/5gNGW8qnch
$nwbo @alphavestcaphttps://t.co/65HPEmeWUU @alphavestcap
— alphavestcapital.com (@alphavestcap) June 6, 2024
💰Meet Michael Castor, Managing Director of Sio Capital Management and newest NWBO institutional investor💰$NWBO
— hoffmann6383 (@hoffmann6383) June 5, 2024
June 4, 2024 8-K
“On June 4, 2024, Northwest Biotherapeutics, Inc. (the “Company”) entered into a Stock Purchase Agreement (SPA) with SIO Capital Management… pic.twitter.com/FPD24nndXd
Bright Boy $nwbo @alphavestcap
— alphavestcapital.com (@alphavestcap) June 6, 2024
Re: SkyLimit2022 post# 696562
Thursday, June 06, 2024 1:55:18 PM
Post# of 696628 Go
And as important as the dollar value is the extensive DD required for SIO to invest in anything. That speaks volumes about their investment decision/Northwest's…
Single Stock: With your Bloomberg, could you run SIO versus biotech , little, mid, and big since 2005 . Versus the s and p is certainly interesting,but considering the more volatile biotech industry as its more near peer , it would be illuminating to see how SIO fared against the three heathcare sectiors . Thanks , and please give the King my best.A.E.K.
Re: ae kusterer post# 696484
Thursday, June 06, 2024 7:51:26 AM
Post#
696485
of 696627
Here ya go `Study of Biotech and Large Pharma` with Market cap > $3bn shows a multiplier
between total annual revenue and market cap of about 5.5 x
That'll do ...
$nwbo @alphavestcap pic.twitter.com/b0tP81dIrT
— alphavestcapital.com (@alphavestcap) June 6, 2024
https://www.instagram.com/jgunnarofficial/ (announced on joseph gunnar instagram page about 2 hours ago)
Single Stock:
If Sawston were generating $1.2 billion in revenues , I believe the bids at auction would be 20x those revenues because Sawston would be a model for global growth potential.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=174552339
Re: ae kusterer post# 696484
Thursday, June 06, 2024 7:51:26 AM
Post#
696485
of 696488
Here ya go `Study of Biotech and Large Pharma` with Market cap > $3bn shows a multiplier
between total annual revenue and market cap of about 5.5 x
That'll do ...
ae kusterer
Re: Single Stock post# 696298
Thursday, June 06, 2024 7:44:48 AM
Post#
696484
of 696489
Single Stock: 6000 dc vax L patient doses annually in the U.K.= $1.2 billion in Sawston annual revenues. North America would be 2x that. $1.0 billion of the $1.2 billion drops to FCF(free cash flow). Please tell me whether or not you agree that a 20x fcf multiple would be the average bid by major biotechs, just to own Sawston .
Re: None
Wednesday, June 05, 2024 12:11:13 PM
Post#
696298
of 696483
$8.4 Bn M/C with approx 6,000 GBM in UK annually x $200,000 x 7 ( market multiplier )
Chat GBT :
Incidence rate: General GBM incidence in the UK is estimated around eight new cases per 100,000 people each year [1].
UK population: With a population of roughly 67 million, this translates to approximately (8 cases/100,000 people) * (67,000,000 people) = 5,360 cases per year (approx.) for all GBM.
Alternative approach:
Brain tumor statistics: Cancer Research UK reports around 6,700 new cases of brain and central nervous system (CNS) tumors diagnosed annually in females and 6,100 in males (combined data likely includes nGBM) [2].
martyDg: your mental acquity is wanting .
This direct investment by SIO Capital Management to purchase 8,125,000 shares of $NWBO IMO means that SIO Capital, with $1.4 billion AUM, will protect their investment by ensuring that NWBO has enough capital & working capital through #DCVax-L approvals in the UK, then US,… pic.twitter.com/tyrZr20Azn
— ATLnsider (@ATLnsider) June 5, 2024
Sio Capital Management, the first of many institutional funds to invest in $NWBO, tip of the iceberg, LP is driving the bus not the institutions, NW just needs enough gas to get over the finish line!🤟😄Great post Single Stock (BSB) pic.twitter.com/lgh1CXguDJ
— Hspooner (@Hspooner665) June 6, 2024
Single Stock: 6000 dc vax L patient doses annually in the U.K.= $1.2 billion in Sawston annual revenues. North America would be 2x that. $1.0 billion of the $1.2 billion drops to FCF(free cash flow). Please tell me whether or not you agree that a 20x fcf multiple would be the average bid by major biotechs, just to own Sawston .
Re: None
Wednesday, June 05, 2024 12:11:13 PM
Post#
696298
of 696483
$8.4 Bn M/C with approx 6,000 GBM in UK annually x $200,000 x 7 ( market multiplier )
Chat GBT :
Incidence rate: General GBM incidence in the UK is estimated around eight new cases per 100,000 people each year [1].
UK population: With a population of roughly 67 million, this translates to approximately (8 cases/100,000 people) * (67,000,000 people) = 5,360 cases per year (approx.) for all GBM.
Alternative approach:
Brain tumor statistics: Cancer Research UK reports around 6,700 new cases of brain and central nervous system (CNS) tumors diagnosed annually in females and 6,100 in males (combined data likely includes nGBM) [2].
Bright Boy
Re: Single Stock post# 696158
Wednesday, June 05, 2024 10:43:41 AM
Thanks a mil for your excellent assessment! I know you are very well respected in the highest investment circles in global finance , including my highly influential friends in the UK and Europe. I too believe this is a very important first step in the direction of many future successes for Northwest on the Global Healthcare Stage!!!
Cheers,
BB
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=174545019
Single Stock
Re: The Danish Dude post# 696154
Wednesday, June 05, 2024 6:11:46 AM
SIO are an institutional investor and whilst their profile will say `long / short` they are `long only` , see below , and Danish Dudes post SHOWING ZERO SHORT POSITIONS
So on a positive note they are not a `Chardan Capital` who would have shorted the second the call came in from Linda Powers (seriously)
To remind those old timers here, Woodford invested via private placement then bought on the open market, then invested two more tranches I believe.
Are SIO a `name` in healthcare investments , not really but on this embarrassment of an exchange we are lucky to have them and should they now buy on the open market with our abysmal daily volumes of sub 2m a day then it would have a significant impact.
Single Stock: when you you think a prospectus gets filed. The "use of proceeds " section could be interstinmg reading. The next combo trial component formula ( Dc vax L, poly iclc, CSF) ?
https://trp.cancer.gov/spores/abstracts/ucla_brain.htm
Re: Kap10jak post# 696177
Wednesday, June 05, 2024 8:24:59 AM
Post#
696179
of 696181
That`s a normal pre agreed investment plan , so yes hopefully
Does the SEC require a prospectus, with a "use of proceeds " section ?
$nwbo @alphavestcap @BrianEgolf2 @SmithOnStocks1 @hoffmann6383 @metacollectiveG @ATLnsider @TiltMyBrain @glen_bwrhr42
— alphavestcapital.com (@alphavestcap) June 4, 2024
a new capital market strategy ?
"Use of Proceeds
Item 504 of Regulation S-K sets forth the requirements for companies to disclose the principal purposes for…
kabunushi: how many clients does Joseph Gunnar have?
Re: attilathehunt post# 696088
Tuesday, June 04, 2024 8:06:40 PM
Post#
696096
of 696098
The amount of the offering is smaller than their cash burn. And they wrote in the 8-k that "The funds will be used for the Company’s ongoing business operations.". I believe they are pretty confident that the approval will come within a few months and they will be able to sell shares after that goal is achieved at a higher price. Hence this seems likely to be only what they need to keep their payments current against mundane ongoing costs.
attilathehunt:please post all time and sales today. Thanks.A.E.K.
Re: flipper44 post# 695918
Tuesday, June 04, 2024 12:53:16 PM
Post#
695934
of 695946
Whats with all those 3300 share trades? Over 30 of them...Some kind of message?
mRNA Cancer Vaccines: Development
https://x.com/alphavestcap/status/1797574828477562938
June 3, 2024
Anonymous
Both Merck / Moderna and BioNTech are having trials regarding researching mRNA cancer vaccines. Can you please tell me about these?
ChatGPT
Merck and Moderna, as well as BioNTech, are actively involved in developing mRNA-based cancer vaccines, which represent a promising new approach to cancer treatment.
Merck and Moderna
Merck and Moderna are collaborating on an investigational personalized mRNA cancer vaccine known as mRNA-4157 (or V940). This vaccine is designed to be used in combination with Merck's PD-1 inhibitor, Keytruda (pembrolizumab), for the treatment of high-risk melanoma following surgical resection. The combination therapy aims to improve recurrence-free survival rates by inducing a robust immune response against tumor-specific antigens identified from the patient's tumor profile.
The Phase 2b trial, KEYNOTE-942, showed that the combination reduced the risk of recurrence or death by 44% compared to Keytruda alone. This positive result led to the initiation of a larger Phase 3 trial (V940-001), which began in August 2023. This trial will enroll over 1,000 patients and aims to further assess the efficacy and safety of the vaccine combination in a broader patient population, including those with stage IIB to IV melanoma? (merck)?? (fiercebiotech)?? (nature)?.
BioNTech
BioNTech, in collaboration with Genentech, is developing an mRNA vaccine named autogene cevumeran for pancreatic ductal adenocarcinoma (PDAC). This vaccine encodes up to 20 neoantigens personalized for each patient and is administered alongside the immune checkpoint inhibitor atezolizumab and standard chemotherapy. The Phase II trial, which began recently, aims to evaluate the vaccine's efficacy in preventing cancer recurrence and improving survival rates in PDAC patients, a particularly challenging cancer to treat due to its high relapse rate? (biospace)?.
BioNTech is also testing autogene cevumeran in Phase II trials for colorectal cancer and melanoma, reflecting the broad potential of this personalized mRNA approach across various cancer types? (biospace)?.
These mRNA cancer vaccines represent a significant advancement in oncology, leveraging the body's immune system to target cancer cells more effectively and potentially offering new hope for patients with difficult-to-treat cancers.
Anonymous
When is it expected that these trials have finished their Phase 3 trials and are ready for marketing approval?
ChatGPT
ChatGPT
Searched 3 sites
The Phase 3 trials for the Merck and Moderna mRNA cancer vaccine (mRNA-4157, also known as V940) are currently underway. These trials are expected to provide crucial data on the efficacy and safety of the vaccine in combination with Keytruda (pembrolizumab) for the treatment of high-risk melanoma and non-small cell lung cancer (NSCLC).
Melanoma Trial (V940-001)
The Phase 3 trial for high-risk melanoma (INTerpath-001) began in August 2023. This study aims to enroll 1,089 patients and will measure recurrence-free survival (RFS) as its primary endpoint. The estimated primary completion date for this trial is October 2029? (classic.clinicaltrials)?? (pharmexec)?.
NSCLC Trial (INTerpath-002)
Another Phase 3 trial (INTerpath-002) is evaluating the same vaccine combination in patients with completely resected Stage II, IIIA, or IIIB non-small cell lung cancer. This trial also started in 2023 and aims to enroll 868 participants, with a primary focus on disease-free survival (DFS). The completion date for this trial has not been explicitly stated but will likely align closely with the melanoma trial's timeline? (pharmexec)?.
BioNTech's Cancer Vaccine
BioNTech is conducting a Phase 2 trial for its mRNA vaccine, autogene cevumeran, targeting pancreatic ductal adenocarcinoma (PDAC). This trial, which started in late 2023, aims to recruit 206 patients and is expected to be completed by 2029? (biospace)?.
Given the complexity and duration of these trials, marketing approval for these vaccines is not expected until the trials are completed and the data thoroughly analyzed, likely by the early 2030s if the results are favorable and regulatory approvals are granted.
Anonymous
Can you tell me about their manufactoring process, how long time it takes to make a personalized cancer vaccine for 1 person?
ChatGPT
ChatGPT
The manufacturing process for personalized mRNA cancer vaccines involves several intricate steps designed to tailor the vaccine to the specific mutations present in an individual's tumor. Here’s an overview of the process:
1. Tumor Sample Collection and Sequencing
Tumor Biopsy: A sample of the patient’s tumor is collected through a biopsy.
Sequencing: The tumor’s DNA is sequenced to identify unique mutations or neoantigens that are specific to the cancer cells.
2. Neoantigen Identification
Bioinformatics Analysis: Using advanced bioinformatics tools, the sequencing data is analyzed to identify neoantigens – proteins that arise from tumor-specific mutations and are not present in normal cells.
3. Vaccine Design
mRNA Design: The identified neoantigens are used to design synthetic mRNA sequences that will be encoded in the vaccine. Each mRNA sequence corresponds to a specific neoantigen.
4. mRNA Synthesis
Synthesis: The designed mRNA sequences are synthesized in the laboratory. This step involves transcribing DNA templates into mRNA molecules.
Purification: The synthesized mRNA is then purified to remove any impurities and ensure the integrity of the vaccine.
5. Formulation
Lipid Nanoparticles (LNPs): The mRNA is encapsulated within lipid nanoparticles to protect it from degradation and facilitate its delivery into cells.
Formulation: The mRNA-loaded LNPs are formulated into the final vaccine product.
6. Quality Control
Testing: The final vaccine undergoes rigorous quality control testing to ensure its safety, potency, and purity.
7. Administration
Injection: The personalized vaccine is administered to the patient, typically via intramuscular injection.
Timeframe
The entire process from tumor biopsy to vaccine administration typically takes several weeks. The exact timeframe can vary but generally spans around 4-8 weeks. This includes the time needed for sequencing, neoantigen identification, mRNA synthesis, and quality control.
Manufacturing Scale and Efficiency
Advances in mRNA technology and manufacturing processes have made it possible to produce personalized vaccines more rapidly than traditional methods. Companies like Moderna and BioNTech have developed scalable manufacturing platforms that can expedite the production of personalized mRNA vaccines. These platforms leverage high-throughput sequencing and automated bioinformatics pipelines to streamline the process.
Key Considerations
Personalization: Each vaccine is unique to the individual, tailored to the specific genetic makeup of their tumor.
Flexibility: mRNA technology allows for rapid adjustments if the tumor evolves or new mutations are discovered.
Storage and Distribution: The vaccines typically require cold storage to maintain stability, which can be a logistical challenge.
Conclusion
The personalized mRNA cancer vaccine manufacturing process is a cutting-edge approach that leverages the body's immune system to target cancer cells more precisely. The process is complex but has the potential to revolutionize cancer treatment by offering highly individualized therapies.
Sources:
Nature
ClinicalTrials.gov
Moderna's Press Release
Anonymous
Northwest Biotherapeutics have filed for marketing approval in the UK for DCvax-L. They have been manufactoring the personalized vaccine in clean rooms, but are almost ready with the Flaskworks manufacturing system Eden and a GMP-grade unit, which will take care of the manufactoring and scaling of DCvax-L in the future.
https://nwbio.com/northwest-biotherapeutics-moves-from-optimization-of-flaskworks-prototype-to-fabrication-of-gmp-compliant-units-for-installation-validation-and-final-testing-prior-to-regulatory-certification/
Can you please explain the difference in manufactoring of these personalized vaccines, the mRNA versus DCvax-L and how long time it takes for NWBO to manufacture DCVax-L with Flaskworks Eden?
ChatGPT
ChatGPT
Searched 4 sites
The manufacturing processes for personalized mRNA cancer vaccines like those from Moderna and Merck, and for DCVax-L from Northwest Biotherapeutics (NWBO), involve distinct methods due to the nature of the products.
mRNA Cancer Vaccine Manufacturing
Process:
Tumor Sample Collection: A tumor biopsy is performed to obtain a sample.
Sequencing and Neoantigen Identification: The tumor’s DNA is sequenced to identify specific mutations or neoantigens.
mRNA Design and Synthesis: mRNA sequences coding for these neoantigens are synthesized.
Formulation: The mRNA is encapsulated in lipid nanoparticles to protect it and facilitate delivery into cells.
Quality Control and Administration: The vaccine undergoes rigorous testing before being administered to the patient.
Timeframe:
This process typically takes around 4-8 weeks from the biopsy to the administration of the vaccine.
DCVax-L Manufacturing
Process:
Tumor Sample Collection and Dendritic Cell Isolation: A sample is collected, and dendritic cells are isolated from the patient’s blood.
Cell Culture and Activation: These cells are cultured and activated with tumor antigens.
Formulation and Cryopreservation: The activated dendritic cells are formulated into a vaccine and cryopreserved for storage.
Flaskworks Eden System:
The Flaskworks Eden system automates and closes the DCVax-L manufacturing process, addressing several challenges:
Closed System: Reduces the need for high-grade clean rooms by eliminating open steps.
Automation: Automates key steps like cell isolation, culturing, and extraction, which traditionally required skilled technicians.
Batch Production: The entire process for a patient’s treatment over several years can be completed in a single 8-day batch, after which the doses are cryopreserved.
Timeframe:
The automated Flaskworks system aims to mirror the manual process, which currently takes about 8 days to produce the full set of doses for a patient. The new system is expected to streamline production and reduce costs significantly, making it feasible to scale up for large numbers of patients? (nwbio)?? (nwbio)?? (greenstocknews)?.
Both manufacturing processes involve cutting-edge technology and significant automation to ensure precision, safety, and scalability, but they are tailored to the specific requirements of mRNA and dendritic cell-based therapies.
Anonymous
Tell me about the vaccines how they target neo-antigens and cons and pros?
ChatGPT
ChatGPT
Neoantigen-Targeting Vaccines: mRNA and Dendritic Cell-Based Approaches
mRNA Vaccines (Moderna and Merck)
Mechanism:
Tumor Sequencing: A sample of the patient’s tumor is sequenced to identify unique mutations or neoantigens.
mRNA Design: Synthetic mRNA sequences corresponding to these neoantigens are designed.
Immune Activation: The mRNA is encapsulated in lipid nanoparticles and injected into the patient. The mRNA instructs cells to produce the neoantigens, which are then presented on the cell surface.
Immune Response: The immune system recognizes these neoantigens as foreign and mounts a targeted attack against the tumor cells expressing them.
Pros:
Personalization: Highly personalized, targeting unique mutations specific to the patient’s tumor.
Rapid Production: mRNA vaccines can be designed and produced relatively quickly.
Versatility: Can be adapted to different types of cancers and mutations.
Cons:
Stability and Storage: Requires careful handling and storage at low temperatures.
Delivery Challenges: Effective delivery of mRNA into cells can be challenging and requires advanced nanoparticle technology.
Immune Response Variability: The effectiveness can vary based on individual immune system responses and the heterogeneity of tumors.
Dendritic Cell-Based Vaccines (DCVax-L by Northwest Biotherapeutics)
Mechanism:
Dendritic Cell Collection: Dendritic cells are isolated from the patient’s blood.
Tumor Antigen Loading: These cells are exposed to antigens from the patient’s tumor, either peptides or lysates, which they then present on their surface.
Activation and Injection: The activated dendritic cells are injected back into the patient, where they stimulate T cells to recognize and attack tumor cells expressing the target antigens.
Pros:
Personalization: Tailored to the patient’s tumor antigens, potentially increasing effectiveness.
Strong Immune Activation: Dendritic cells are potent activators of T cells, leading to a robust immune response.
Specificity: High specificity for tumor antigens reduces the risk of attacking normal tissues.
Cons:
Complex Manufacturing: The process of isolating, culturing, and activating dendritic cells is complex and labor-intensive.
Cost: Production costs are higher due to the personalized nature and complexity of the process.
Scalability: Scaling up production to treat large numbers of patients can be challenging.
Comparative Analysis
Effectiveness:
Both types of vaccines are designed to elicit strong, targeted immune responses against cancer cells. The success of these vaccines in clinical trials shows promise in extending survival and reducing recurrence rates in cancers like melanoma and glioblastoma.
Logistics:
mRNA Vaccines: Easier to scale up and faster to produce, but require stringent storage conditions.
Dendritic Cell Vaccines: More labor-intensive and costly, but potentially offer stronger and more specific immune responses due to the direct involvement of dendritic cells.
Safety:
Both vaccine types have shown acceptable safety profiles in clinical trials. However, the personalized nature of these therapies necessitates careful monitoring for any adverse effects related to the immune response.
Future Prospects:
mRNA Technology: Benefiting from advancements in nanoparticle delivery systems and rapid production capabilities, mRNA vaccines are positioned for broader application across various cancers.
Dendritic Cell Technology: Continued innovations in automation and closed-system manufacturing, like Flaskworks, are making these therapies more accessible and affordable.
Conclusion
Both mRNA and dendritic cell-based vaccines offer groundbreaking approaches to personalized cancer treatment, each with unique advantages and challenges. Ongoing research and technological advancements will continue to optimize these therapies, potentially transforming the landscape of cancer treatment.
Sources:
Moderna’s mRNA Vaccine Technology
Northwest Biotherapeutics’ DCVax-L
ClinicalTrials.gov on DCVax-L and mRNA-4157
Anonymous
How about the number of neo-antigens they target? It seems the mRNA ones target 20-34 specific neo-antigens, while DCVax-L uses tumor cell lysate to ensure a broad-spectrum immune response againnst multiple antigens and uses lysate from patient’s own tumor to ensure correct antigens targeted.
ChatGPT
ChatGPT
Targeting Neoantigens: mRNA vs. DCVax-L Vaccines
mRNA Vaccines (Moderna and Merck)
Neoantigen Targeting:
Number of Neoantigens: mRNA vaccines typically target 20-34 specific neoantigens. These neoantigens are identified through sequencing the patient's tumor DNA and selecting the most immunogenic mutations.
Specificity: By targeting a defined set of neoantigens, these vaccines aim to elicit a strong and focused immune response. Each mRNA sequence corresponds to a specific neoantigen, ensuring precise targeting.
Pros:
Precision: High specificity for selected neoantigens potentially leads to a stronger and more efficient immune response against cancer cells.
Efficiency: The ability to rapidly design and produce the mRNA sequences for these neoantigens allows for quicker vaccine development and customization.
Cons:
Limited Scope: Targeting a specific set of neoantigens might miss other relevant mutations present in the tumor, potentially allowing some cancer cells to evade the immune response.
DCVax-L (Northwest Biotherapeutics)
Neoantigen Targeting:
Number of Neoantigens: DCVax-L uses tumor cell lysate, which contains a broad array of antigens from the patient’s own tumor. This means it can potentially target a wide range of neoantigens present in the tumor.
Broad Spectrum: By using the entire tumor lysate, DCVax-L ensures that the immune response targets multiple antigens, which can be advantageous in dealing with the heterogeneity of cancer cells.
Pros:
Comprehensive Targeting: The broad spectrum of antigens ensures that a wide array of tumor-associated antigens are targeted, reducing the likelihood of immune evasion by cancer cells.
Personalization: The use of tumor lysate from the patient’s own tumor ensures that the vaccine is highly personalized, targeting the specific antigens present in that individual’s cancer.
Cons:
Complexity and Cost: The process of creating a vaccine from tumor lysate is more complex and costly compared to synthesizing mRNA.
Variable Response: The effectiveness can vary based on the quality and composition of the tumor lysate, and it might not always lead to the strongest immune response against all neoantigens.
Comparative Analysis
Scope and Breadth:
mRNA Vaccines: Targeting a specific set of neoantigens allows for precise immune responses but may miss some antigens.
DCVax-L: Uses a broader approach by including multiple antigens from the tumor lysate, potentially offering a more comprehensive immune response.
Personalization:
Both types of vaccines are personalized, but mRNA vaccines are designed based on selected mutations, while DCVax-L uses the entire tumor lysate, capturing a broader antigen profile.
Manufacturing and Cost:
mRNA Vaccines: Generally quicker and more scalable but require advanced technology for delivery and storage.
DCVax-L: More complex and expensive to produce, requiring sophisticated facilities and processes.
Conclusion
Both mRNA and DCVax-L vaccines offer unique advantages in targeting cancer. mRNA vaccines provide precise, targeted responses against selected neoantigens, while DCVax-L offers a broad-spectrum approach by utilizing the entire tumor lysate. The choice between these approaches depends on various factors, including the type of cancer, the patient's specific tumor characteristics, and logistical considerations.
Sources:
Moderna’s mRNA Vaccine Technology
Northwest Biotherapeutics’ DCVax-L
ClinicalTrials.gov on DCVax-L and mRNA-4157
Anonymous
The cons you describe for DCvax-L "More complex and expensive to produce, requiring sophisticated facilities and processes.", would you consider that hurdle "overcome", with the GMP grade production unit of Flaskworks Eden apparatus, if that can create a biosimilar of DCvax-L?
ChatGPT
ChatGPT
The implementation of the Flaskworks Eden system for the production of DCVax-L represents a significant advancement in overcoming some of the traditional hurdles associated with the complexity and cost of producing dendritic cell-based vaccines. Here’s how the Flaskworks Eden system addresses these challenges:
Overcoming Complexity and Cost
Automation and Standardization:
Closed System: The Flaskworks Eden apparatus automates the manufacturing process and converts it into a closed system. This minimizes the risk of contamination and reduces the need for the most stringent cleanroom environments, thereby lowering the overall cost of the facilities required? (nwbio)?? (nwbio)?? (greenstocknews)?.
Reduction in Manual Labor: By automating key steps such as cell isolation, culture, and extraction, the system reduces reliance on highly skilled technicians who previously performed these tasks manually. This makes the process more scalable and less dependent on a limited pool of skilled labor? (nwbio)?? (nwbio)?.
Cost-Effectiveness:
Lower Grade Clean Rooms: The ability to use lower grade clean rooms (grade C instead of grade B) significantly cuts down on the infrastructure costs associated with maintaining high-level sterile environments. This can translate into substantial cost savings over time? (nwbio)?? (greenstocknews)?.
Batch Processing: The Flaskworks system enables the production of multiple patient doses in a single batch, further enhancing efficiency and reducing per-dose costs. This batch processing capability is crucial for scaling up production to meet larger patient demands? (nwbio)?.
Consistency and Quality:
Reproducibility: The automated system ensures consistent production of DCVax-L, maintaining the same composition, purity, and biological characteristics as the manual process. This consistency is essential for regulatory approval and patient safety? (nwbio)?? (greenstocknews)?.
GMP Compliance: The development of GMP-grade units for Flaskworks Eden ensures that the production meets the stringent regulatory standards required for clinical and commercial use. This is a critical step towards broader adoption and scalability of the vaccine production process? (nwbio)?? (greenstocknews)?.
Conclusion
The introduction of the Flaskworks Eden system marks a significant improvement in the manufacturing process for DCVax-L, addressing many of the previous challenges associated with complexity and cost. By automating the process and transitioning to a closed system, Flaskworks Eden makes it feasible to produce DCVax-L in a more efficient, cost-effective, and scalable manner. This advancement not only enhances the potential for broader accessibility of the vaccine but also aligns with regulatory requirements for consistent and high-quality production.
|
XMaster2023
DCVAX is the first treatment in 30 years to move the needle on rGBM. Within a few weeks it should be approved in the UK. Flaskworks is a game changer to assist in the mass production of DCVAX. It resolves many logistical issues in the production of the vaccine. Merck will loose the patent on Keytruda in 2026.
Your analysis is much different than mine. Perhaps your salary is clouding your judgement.
ANYONE HAVE THE TWO POSNER May 31, 2024 DOCUMENTS TO POST HERE ? THANKS IF YOU DO .
Main Document
Declaration in Opposition to Motion
160
May 31, 2024
Main Document
Memorandum of Law in Opposition to Motion
159
May 21, 2024
Main Document
Letter
158
May 8, 2024
ORDER: To conserve resources, to promote judicial efficiency, and in an effort to achieve a faster disposition of this matter, it is hereby ORDERED that the parties must discuss whether they are willing to consent, under 28 U.S.C. § 636(c), to conducting all further proceedings before the assigned Magistrate Judge. If both parties consent to proceed before the Magistrate Judge, counsel for the defendant must, within two weeks of the date of this order file on ECF a fully executed Not ice, Consent, and Reference of a Civil Action to a Magistrate Judge form, a copy of which is attached to this order, as further set forth in this Order. If either party does not consent to conducting all further proceedings before the assigned Ma gistrate Judge, the parties must file a joint letter, within two weeks of the date of this order advising the Court that the parties do not consent, but without disclosing the identity of the party or parties who do not consent. The parties are free to withhold consent without negative consequences. SO ORDERED. (Signed by Judge Gregory H. Woods on 5/8/2024) (vfr)
Main Document
Order
157
May 1, 2024
DECLARATION of William A. Burck in Support re: 155 MOTION to Dismiss Second Amended Complaint.. Document filed by Canaccord Genuity LLC, Citadel Securities LLC, G1 Execution Services LLC, GTS Securities LLC, Instinet LLC, Lime Trading Corp., Virtu Americas LLC. (Attachments: # 1 Exhibit 1 December 7, 2016 PR Newswire Release, # 2 Exhibit 2 NWBO Stock Price (Yahoo), # 3 Exhibit 3 May 10, 2022 STAT Article, # 4 Exhibit 4 NWBO May 10, 2022 Form 10-Q, # 5 Exhibit 5 NWBO November 20, 2017 Form 10-Q, # 6 Exhibit 6 NWBO November 9, 2022 Form 10-Q, # 7 Exhibit 7 In re NWBO (Del. Ch.) Amended Complaint, # 8 Exhibit 8 In re NWBO (Del. Ch.) Original Complaint, # 9 Exhibit 9 31 Alleged Last-Hour Spoofing Episodes, # 10 Exhibit 10 NWBO Stock Price (Bloomberg)).(Burck, William) (Entered: 05/01/2024)
Main Document
Declaration in Support of Motion
156
May 1, 2024
MEMORANDUM OF LAW in Support re: 155 MOTION to Dismiss Second Amended Complaint. . Document filed by Canaccord Genuity LLC, Citadel Securities LLC, G1 Execution Services LLC, GTS Securities LLC, Instinet LLC, Lime Trading Corp., Virtu Americas LLC..(Burck, William) (Entered: 05/01/2024)
Main Document
Memorandum of Law in Support of Motion
155
May 1, 2024
MOTION to Dismiss Second Amended Complaint. Document filed by Canaccord Genuity LLC, Citadel Securities LLC, G1 Execution Services LLC, GTS Securities LLC, Instinet LLC, Lime Trading Corp., Virtu Americas LLC..(Burck, William) (Entered: 05/01/2024)
Main Document
Dismiss
Mar 22, 2024
Set/Reset Deadlines: Motions due by 5/1/2024. Responses due by 5/31/2024. Replies due by 6/14/2024. (ate)
Set/Reset Deadlines
Mar 22, 2024
Order on Motion for Extension of Time
154
Mar 22, 2024
ORDER granting 151 Letter Motion for Extension of Time. Having considered the parties' letters, the Court sets the following briefing schedule for Defendants' motion to dismiss Plaintiff's Second Amended Complaint (Dkt. No. 150): Defendants shall file their single, joint motion to dismiss with supporting papers by May 1, 2024; Plaintiff shall file its opposition by May 31, 2024; and Defendants shall file their reply by June 14, 2024. Defendants are allotted 25 pages for their brief and 10 pages for their reply brief; Plaintiff is allotted 25 pages for its opposition brief. (HEREBY ORDERED by Magistrate Judge Gary Stein)(Text Only Order) (ate) (Entered: 03/22/2024)
Main Document
Order on Motion for Extension of Time
153
Mar 20, 2024
LETTER addressed to Magistrate Judge Gary Stein from William A. Burck dated March 20, 2024 re: Response to Plaintiff Northwest Biotherapeutics, Inc.'s, March 20, 2024 opposition to Defendants' request for a 30-day extension (Dkt. 152). Document filed by Canaccord Genuity LLC, Citadel Securities LLC, G1 Execution Services LLC, GTS Securities LLC, Instinet LLC, Lime Trading Corp., Virtu Americas LLC..(Burck, William) (Entered: 03/20/2024)
Main Document
Letter
152
Mar 20, 2024
LETTER RESPONSE in Opposition to Motion addressed to Magistrate Judge Gary Stein from Laura H. Posner dated March 20, 2024 re: 151 LETTER MOTION for Extension of Time addressed to Magistrate Judge Gary Stein from William Burck dated March 19, 2024. . Document filed by Northwest Biotherapeutics, Inc.. (Attachments: # 1 Exhibit A).(Posner, Laura) (Entered: 03/20/2024)
Main Document
Response in Opposition to Motion
Attachment 1
Exhibit A
151
Mar 19, 2024
LETTER MOTION for Extension of Time addressed to Magistrate Judge Gary Stein from William Burck dated March 19, 2024. Document filed by Citadel Securities LLC..(Burck, William) (Entered: 03/19/2024)
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Motion for Extension of Time
150
Mar 18, 2024
SECOND AMENDED COMPLAINT amending 95 Amended Complaint, against Northwest Biotherapeutics, Inc., Canaccord Genuity LLC, Citadel Securities LLC, G1 Execution Services LLC, GTS Securities LLC, Instinet LLC, Lime Trading Corp., Susquehanna International Group, LLP, Virtu Americas LLC with JURY DEMAND.Document filed by Northwest Biotherapeutics, Inc.. Related document: 95 Amended Complaint,. (Attachments: # 1 Exhibit 1, # 2 Exhibit 2, # 3 Exhibit 3, # 4 Exhibit 4, # 5 Exhibit 5, # 6 Exhibit 6, # 7 Exhibit 7, # 8 Exhibit 8, # 9 Exhibit 9, # 10 Exhibit 10).(Posner, Laura) (Entered: 03/18/2024)
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Amended Complaint
Attachment 1
Exhibit 1
Attachment 2
Exhibit 2
Attachment 3
Exhibit 3
Attachment 4
Exhibit 4
Attachment 5
Exhibit 5
Attachment 6
Exhibit 6
Attachment 7
Exhibit 7
Attachment 8
Exhibit 8
Attachment 9
Exhibit 9
Attachment 10
Exhibit 10
149
Mar 15, 2024
FILING ERROR - DEFICIENT PLEADING - PDF ERROR - SECOND AMENDED COMPLAINT amending 95 Amended Complaint, against Canaccord Genuity LLC, Citadel Securities LLC, G1 Execution Services LLC, GTS Securities LLC, Instinet LLC, Lime Trading Corp., Susquehanna International Group, LLP, Virtu Americas LLC with JURY DEMAND.Document filed by Northwest Biotherapeutics, Inc.. Related document: 95 Amended Complaint,. (Attachments: # 1 Exhibit 1, # 2 Exhibit 2, # 3 Exhibit 3, # 4 Exhibit 4, # 5 Exhibit 5, # 6 Exhibit 6, # 7 Exhibit 7, # 8 Exhibit 8, # 9 Exhibit 9, # 10 Exhibit 10).(Posner, Laura) Modified on 3/18/2024 (pc). (Entered: 03/15/2024)
Main Document
Amended Complaint
Attachment 1
Exhibit 1
Attachment 2
Exhibit 2
Attachment 3
Exhibit 3
Attachment 4
Exhibit 4
Attachment 5
Exhibit 5
Attachment 6
Exhibit 6
Attachment 7
Exhibit 7
Attachment 8
Exhibit 8
Attachment 9
Exhibit 9
Attachment 10
Exhibit 10
148
Feb 14, 2024
ORDER: Adopting REPORT AND RECOMMENDATION: for 137 Report and Recommendation. For the reasons set forth in the R&R, Defendants' motion to dismiss is GRANTED without prejudice. The Clerk of Court is directed to terminate the motion pending at Dkt. No. 114. SO ORDERED. (Signed by Judge Gregory H. Woods on 2/14/2024) (ama) Transmission to Orders and Judgments Clerk for processing. (Entered: 02/14/2024)
Main Document
Order Adopting Report and Recommendations
147
Jan 31, 2024
MEMO ENDORSEMENT on re: 146 Letter filed by Northwest Biotherapeutics, Inc. ENDORSEMENT: The Court has reviewed Defendant's letter at Dkt. No. 145 and Plaintiff's reply here. Defendant's request for leave to file a reply is denied. SO ORDERED. (Signed by Judge Gregory H. Woods on 1/31/2024) (tg) (Entered: 01/31/2024)
Main Document
Memo Endorsement
146
Jan 30, 2024
LETTER addressed to Judge Gregory H. Woods from Laura H. Posner dated January 30, 2024 re: In Response to Defendant's Letter (ECF 145). Document filed by Northwest Biotherapeutics, Inc...(Posner, Laura) (Entered: 01/30/2024)
Main Document
Letter
145
Jan 30, 2024
LETTER addressed to Judge Gregory H. Woods from William A. Burck dated January 30, 2024 re: Leave to file brief reply in support of Defendants' Objections (ECF 141) to Report and Recommendation of Magistrate Judge (ECF 137), pursuant to Rule 3(H) of the Court's Individual Rules of Practice in Civil Cases. Document filed by Canaccord Genuity LLC, Citadel Securities LLC, G1 Execution Services LLC, GTS Securities LLC, Instinet LLC, Lime Trading Corp., Virtu Americas LLC..(Burck, William) (Entered: 01/30/2024)
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Letter
144
Jan 26, 2024
RESPONSE re: 141 Objection to Report and Recommendations . Document filed by Northwest Biotherapeutics, Inc...(Posner, Laura) (Entered: 01/26/2024)
Main Document
Response
143
Jan 26, 2024
RESPONSE re: 142 Objection to Report and Recommendations . Document filed by Canaccord Genuity LLC, Citadel Securities LLC, G1 Execution Services LLC, GTS Securities LLC, Instinet LLC, Lime Trading Corp., Virtu Americas LLC..(Burck, William) (Entered: 01/26/2024)
Main Document
Response
142
Jan 12, 2024
OBJECTION to 137 Report and Recommendations Document filed by Northwest Biotherapeutics, Inc.. (Attachments: # 1 Exhibit A).(Posner, Laura) (Entered: 01/12/2024)
Main Document
Objection to Report and Recommendations
Attachment 1
Exhibit A
141
Jan 12, 2024
OBJECTION to 137 Report and Recommendations Document filed by Canaccord Genuity LLC, Citadel Securities LLC, G1 Execution Services LLC, GTS Securities LLC, Instinet LLC, Lime Trading Corp., Virtu Americas LLC..(Burck, William) (Entered: 01/12/2024)
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Objection to Report and Recommendations
140
Jan 5, 2024
MEMO ENDORSEMENT on re: 139 Response filed by Northwest Biotherapeutics, Inc. ENDORSEMENT: The Court has reviewed Defendants' letter at Dkt. No. 138 and Plaintiff's response at Dkt. No. 139. Defendants' application, Dkt. No. 138, is denied. Any objections to Judge Stein's Report and Recommendation, Dkt. No. 137, are due no later than January 12, 2024. ( Objections to R&R due by 1/12/2024) (Signed by Judge Gregory H. Woods on 1/5/2024) (rro) (Entered: 01/05/2024)
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Memo Endorsement
139
Jan 5, 2024
RESPONSE re: 138 Letter addressed to Gregory Woods from Laura H. Posner dated January 5, 2024 in response to Defendant's January 4, 2024 letter. Document filed by Northwest Biotherapeutics, Inc...(Posner, Laura) (Entered: 01/05/2024)
Main Document
Response
138
Jan 4, 2024
LETTER addressed to Judge Gregory H. Woods from William A. Burck dated January 4, 2024 re: Extension of Time to File Objections to Report and Recommendation. Document filed by Citadel Securities LLC..(Burck, William) (Entered: 01/04/2024)
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Letter
137
Dec 29, 2023
REPORT AND RECOMMENDATION re: 114 MOTION to Dismiss Amended Complaint. filed by G1 Execution Services LLC, Lime Trading Corp., Virtu Americas LLC, GTS Securities LLC, Citadel Securities LLC, Canaccord Genuity LLC, Instinet LLC. For the reasons stated above, the Court concludes and respectfully recommends that Defendants' motion to dismiss be GRANTED. Since the Court does not believe that an amendment would be futile, the Court further recommends that Plaintiff be given leave to file a further amended complaint attempting to cure the deficiencies in the FAC's loss causation allegations Objections to R&R due by 1/12/2024. (Signed by Magistrate Judge Gary Stein on 12/29/2023) (rro) (Entered: 12/29/2023)
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Report and Recommendations
136
Nov 22, 2023
LETTER addressed to Magistrate Judge Gary Stein from Laura H. Posner dated November 22, 2023 re: in response to Defendant's November 20, 2023 letter 133 . Document filed by Northwest Biotherapeutics, Inc...(Posner, Laura) (Entered: 11/22/2023)
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Letter
135
Nov 20, 2023
NOTICE OF FILING OF OFFICIAL TRANSCRIPT Notice is hereby given that an official transcript of a CONFERENCE proceeding held on 11/14/2023 has been filed by the court reporter/transcriber in the above-captioned matter. The parties have seven (7) calendar days to file with the court a Notice of Intent to Request Redaction of this transcript. If no such Notice is filed, the transcript may be made remotely electronically available to the public without redaction after 90 calendar days....(McGuirk, Kelly) (Entered: 11/20/2023)
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Notice of Filing Transcript
134
Nov 20, 2023
TRANSCRIPT of Proceedings re: ORAL ARGUMENT held on 11/14/2023 before Magistrate Judge Gary Stein. Court Reporter/Transcriber: Carol Ganley, (212) 805-0300. Transcript may be viewed at the court public terminal or purchased through the Court Reporter/Transcriber before the deadline for Release of Transcript Restriction. After that date it may be obtained through PACER. Redaction Request due 12/11/2023. Redacted Transcript Deadline set for 12/21/2023. Release of Transcript Restriction set for 2/20/2024..(McGuirk, Kelly) (Entered: 11/20/2023)
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Transcript
133
Nov 20, 2023
LETTER addressed to Magistrate Judge Gary Stein from William A. Burck dated November 20, 2023 re: 133 Oral Argument. Document filed by Canaccord Genuity LLC, Citadel Securities LLC, G1 Execution Services LLC, GTS Securities LLC, Instinet LLC, Lime Trading Corp., Virtu Americas LLC..(Burck, William) (Entered: 11/20/2023)
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Letter
Nov 14, 2023
Oral Argument
132
Nov 13, 2023
ORDER: The following Order is subject to the definitions, obligations and restrictions imposed pursuant to Standing Order M10-468, as Revised. Upon submission of written application to this Court, it is hereby ORDERED that the following attorney(s) are authorized to bring the Personal Electronic Device(s) and/ or the General Purpose Computing Device(s) (collectively, "Devices") listed below into the Courthouse for use in a proceeding or trial in the action captioned: Northwest Biotherapeutics, Inc. v. Canaccord Genuity LLC et al., 1-22-cv-10185-GHW-GS. ORDERED that for the device(s) checked below SDNY Courtroom WI-FI access shall be provided. The date(s) for which such authorization is provided is (are) Nov. 14, 2023. As further set forth by this Order. SO ORDERED. (Signed by Magistrate Judge Gary Stein on 11/13/2023) (tg) (Entered: 11/13/2023)
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Order
131
Nov 9, 2023
LETTER addressed to Magistrate Judge Gary Stein from William A. Burck dated November 9, 2023 re: Electronic Devices. Document filed by Citadel Securities LLC. (Attachments: # 1 Proposed Order re: Electronic Devices).(Burck, William) (Entered: 11/09/2023)
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Letter
Attachment 1
Proposed Order re: Electronic Devices
130
Oct 10, 2023
MEMO ENDORSEMENT on re: 129 Proposed Order for Withdrawal of Attorney filed by Virtu Americas LLC. ENDORSEMENT: Attorney Daniel S. Sinnreich is granted leave to withdraw as counsel for Defendant Virtu Americas LLC. The Clerk of Court is instructed to terminate Attorney Daniel S. Sinnreich from the list of active counsel in this case. Attorney Daniel Shiah Sinnreich terminated. (Signed by Judge Gregory H. Woods on 10/10/2023) (rro) (Entered: 10/11/2023)
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Memo Endorsement
129
Oct 10, 2023
PROPOSED ORDER FOR WITHDRAWAL OF ATTORNEY. Document filed by Virtu Americas LLC..(Sinnreich, Daniel) (Entered: 10/10/2023)
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Proposed Order for Withdrawal of Attorney
128
Oct 6, 2023
RESPONSE re: 127 Notice (Other) of Supplemental Authority. Document filed by Canaccord Genuity LLC, Citadel Securities LLC, G1 Execution Services LLC, GTS Securities LLC, Instinet LLC, Lime Trading Corp., Virtu Americas LLC..(Burck, William) (Entered: 10/06/2023)
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Response
127
Sep 29, 2023
NOTICE of Supplemental Authority re: 123 Memorandum of Law in Opposition to Motion. Document filed by Northwest Biotherapeutics, Inc.. (Attachments: # 1 Exhibit A).(Posner, Laura) (Entered: 09/29/2023)
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Notice (Other)
Attachment 1
Exhibit A
126
Sep 28, 2023
ORDER SCHEDULING ORAL ARGUMENT: An oral argument on Defendants' motion to dismiss the Amended Complaint is scheduled for Tuesday, November 14, 2023 at 10:30AM in Courtroom 9A, United States Courthouse, 500 Pearl Street, New York, New York 10007. SO ORDERED. ( Oral Argument set for 11/14/2023 at 10:30 AM in Courtroom 9A, 500 Pearl Street, New York, NY 10007 before Magistrate Judge Gary Stein.) (Signed by Magistrate Judge Gary Stein on 9/28/2023) (vfr) (Entered: 09/28/2023)
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Order
125
Sep 27, 2023
LETTER addressed to Magistrate Judge Gary Stein from William A. Burck dated September 27, 2023 re: Requesting Oral Argument on Defendants' Motion to Dismiss. Document filed by Canaccord Genuity LLC, Citadel Securities LLC, G1 Execution Services LLC, GTS Securities LLC, Instinet LLC, Lime Trading Corp., Virtu Americas LLC..(Burck, William) (Entered: 09/27/2023)
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Letter
124
Sep 27, 2023
REPLY MEMORANDUM OF LAW in Support re: 114 MOTION to Dismiss Amended Complaint. (Defendants' Joint Reply Memorandum of Law in Support of Motion to Dismiss Amended Complaint). Document filed by Canaccord Genuity LLC, Citadel Securities LLC, G1 Execution Services LLC, GTS Securities LLC, Instinet LLC, Lime Trading Corp., Virtu Americas LLC..(Burck, William) (Entered: 09/27/2023)
Main Document
Reply Memorandum of Law in Support of Motion
Sep 19, 2023
NOTICE OF REASSIGNMENT OF A REFERRAL TO ANOTHER MAGISTRATE JUDGE. The referral in the above entitled action has been reassigned to Magistrate Judge Gary Stein, for General Pretrial (includes scheduling, discovery, non-dispositive pretrial motions, and settlement) and Dispositive Motion (i.e., motion requiring a Report and Recommendation). Magistrate Judge Gabriel W. Gorenstein no longer referred to the case. Motions referred to Gary Stein..(tro)
Notice of Reassignment of Referral to Magistrate Judge
Sep 19, 2023
NOTICE OF REDESIGNATION TO ANOTHER MAGISTRATE JUDGE. The above entitled action has been redesignated to Magistrate Judge Gary Stein. Please note that this is a reassignment of the designation only. (tro)
Notice of Redesignation to Magistrate Judge
123
Aug 25, 2023
MEMORANDUM OF LAW in Opposition re: 114 MOTION to Dismiss Amended Complaint. . Document filed by Northwest Biotherapeutics, Inc...(Posner, Laura) (Entered: 08/25/2023)
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Memorandum of Law in Opposition to Motion
122
Aug 23, 2023
ORDER granting 120 Motion for Laura E. Krabill to Appear Pro Hac Vice. (HEREBY ORDERED by Judge Gregory H. Woods)(Text Only Order) (wv) (Entered: 08/23/2023)
Main Document
Order on Motion to Appear Pro Hac Vice
Aug 23, 2023
Order on Motion to Appear Pro Hac Vice
121
Aug 23, 2023
ORDER granting 119 Motion for Benjamin C. Levine to Appear Pro Hac Vice. (HEREBY ORDERED by Judge Gregory H. Woods)(Text Only Order) (wv) (Entered: 08/23/2023)
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Order on Motion to Appear Pro Hac Vice
Aug 22, 2023
>>>NOTICE REGARDING PRO HAC VICE MOTION. Regarding Document No. 120 MOTION for Laura E. Krabill to Appear Pro Hac Vice . Filing fee $ 200.00, receipt number ANYSDC-28183293. Motion and supporting papers to be reviewed by Clerk's Office staff.. The document has been reviewed and there are no deficiencies. (vba)
Notice Regarding Pro Hac Vice Motion
120
Aug 22, 2023
MOTION for Laura E. Krabill to Appear Pro Hac Vice . Filing fee $ 200.00, receipt number ANYSDC-28183293. Motion and supporting papers to be reviewed by Clerk's Office staff. Document filed by G1 Execution Services LLC. (Attachments: # 1 Affidavit Supporting Declaration, # 2 Exhibit 1 - certificates of good standing, # 3 Proposed Order Proposed Order).(Krabill, Laura) (Entered: 08/22/2023)
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Motion to Appear Pro Hac Vice
Attachment 1
Affidavit Supporting Declaration
Attachment 2
Exhibit 1 - certificates of good standing
Attachment 3
Proposed Order Proposed Order
Aug 21, 2023
>>>NOTICE REGARDING PRO HAC VICE MOTION. Regarding Document No. 119 MOTION for Benjamin C. Levine to Appear Pro Hac Vice . Filing fee $ 200.00, receipt number ANYSDC-28175103. Motion and supporting papers to be reviewed by Clerk's Office staff.. The document has been reviewed and there are no deficiencies. (vba)
Notice Regarding Pro Hac Vice Motion
119
Aug 21, 2023
MOTION for Benjamin C. Levine to Appear Pro Hac Vice . Filing fee $ 200.00, receipt number ANYSDC-28175103. Motion and supporting papers to be reviewed by Clerk's Office staff. Document filed by GTS Securities LLC. (Attachments: # 1 Affidavit Of Benjamin C. Levine In Support; With Certificate Of Good Standing, # 2 Proposed Order For Admission Pro Hac Vice).(Levine, Benjamin) (Entered: 08/21/2023)
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Motion to Appear Pro Hac Vice
Attachment 1
Affidavit Of Benjamin C. Levine In Support; With Certificate Of Good Standing
Attachment 2
Proposed Order For Admission Pro Hac Vice
118
Aug 2, 2023
ORDER GRANTING MOTION TO WITHDRAW AS COUNSEL granting 117 Motion to Withdraw as Attorney. The motion of Hannah O. Koesterer to withdraw as counsel on behalf of GTS Securities, LLC, and for Hannah O. Koesterer to be removed from the CM/ECF service list for this matter, is GRANTED. Attorney Hannah Olivia Koesterer terminated. (Signed by Magistrate Judge Gabriel W. Gorenstein on 8/2/2023) (rro) (Entered: 08/02/2023)
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Order on Motion to Withdraw as Attorney
117
Aug 1, 2023
MOTION for Hannah O. Koesterer to Withdraw as Attorney . Document filed by GTS Securities LLC. (Attachments: # 1 Proposed Order To Withdraw As Counsel).(Koesterer, Hannah) (Entered: 08/01/2023)
Main Document
Motion to Withdraw as Attorney
Attachment 1
Proposed Order To Withdraw As Counsel
116
Jul 12, 2023
DECLARATION of William A. Burck in Support re: 114 MOTION to Dismiss Amended Complaint.. Document filed by Canaccord Genuity LLC, Citadel Securities LLC, G1 Execution Services LLC, GTS Securities LLC, Instinet LLC, Lime Trading Corp., Virtu Americas LLC. (Attachments: # 1 Exhibit 1- U.S. Equity Market Structure (SEC), # 2 Exhibit 2- May 10, 2022 STAT Article, # 3 Exhibit 3- NWBO 2019 Form 10-K, # 4 Exhibit 4- NWBO 2020 Form 10-K, # 5 Exhibit 5- NWBO Dec. 9, 2016 Form 8-K, # 6 Exhibit 6- NWBO Stock Price, # 7 Exhibit 7- Over-the-Counter Market (SEC), # 8 Exhibit 8- OTC Markets Broker Dealer Directory, # 9 Exhibit 9- OTC Link FIXIE Quote Specification, # 10 Exhibit 10- Speed of Equity Markets (SEC), # 11 Exhibit 11- October 12, 2020 OTC Link Quote Data, # 12 Exhibit 12- January 11, 2021 OTC Link BBO Data, # 13 Exhibit 13- October 15, 2020 OTC Link Quote Data, # 14 Exhibit 14- October 27, 2020 OTC Link Quote Data, # 15 Exhibit 15- October 20, 2020 OTC Link Quote Data, # 16 Exhibit 16- November 2, 2020 OTC Link Quote Data, # 17 Exhibit 17- November 18, 2020 OTC Link Quote Data, # 18 Exhibit 18- December 24, 2020 OTC Link Quote Data, # 19 Exhibit 19- February 1, 2021 OTC Link Quote Data Part 1, # 20 Exhibit 20- February 1, 2021 OTC Link Quote Data Part 2, # 21 Exhibit 21- May 17, 2021 OTC Link Quote Data, # 22 Exhibit 22- May 9, 2022 OTC Link Quote Data, # 23 Exhibit 23- May 10, 2022 OTC Link Quote Data Part 1, # 24 Exhibit 24- May 10, 2022 OTC Link Quote Data Part 2, # 25 Exhibit 25- May 10, 2022 OTC Link Quote Data Part 3, # 26 Exhibit 26- May 10, 2022 OTC Link Quote Data Part 4, # 27 Exhibit 27- May 10, 2022 OTC Link Quote Data Part 5, # 28 Exhibit 28- May 10, 2022 OTC Link Trade Data).(Burck, William) (Entered: 07/12/2023)
Main Document
Declaration in Support of Motion
Attachment 1
Exhibit 1- U.S. Equity Market Structure (SEC)
Attachment 2
Exhibit 2- May 10, 2022 STAT Article
Attachment 3
Exhibit 3- NWBO 2019 Form 10-K
Attachment 4
Exhibit 4- NWBO 2020 Form 10-K
Attachment 5
Exhibit 5- NWBO Dec. 9, 2016 Form 8-K
Attachment 6
Exhibit 6- NWBO Stock Price
Attachment 7
Exhibit 7- Over-the-Counter Market (SEC)
Attachment 8
Exhibit 8- OTC Markets Broker Dealer Directory
Attachment 9
Exhibit 9- OTC Link FIXIE Quote Specification
Attachment 10
Exhibit 10- Speed of Equity Markets (SEC)
Attachment 11
Exhibit 11- October 12, 2020 OTC Link Quote Data
Attachment 12
Exhibit 12- January 11, 2021 OTC Link BBO Data
Attachment 13
Exhibit 13- October 15, 2020 OTC Link Quote Data
Attachment 14
Exhibit 14- October 27, 2020 OTC Link Quote Data
Attachment 15
Exhibit 15- October 20, 2020 OTC Link Quote Data
Attachment 16
Exhibit 16- November 2, 2020 OTC Link Quote Data
Attachment 17
Exhibit 17- November 18, 2020 OTC Link Quote Data
Attachment 18
Exhibit 18- December 24, 2020 OTC Link Quote Data
Attachment 19
Exhibit 19- February 1, 2021 OTC Link Quote Data Part 1
Attachment 20
Exhibit 20- February 1, 2021 OTC Link Quote Data Part 2
Attachment 21
Exhibit 21- May 17, 2021 OTC Link Quote Data
Attachment 22
Exhibit 22- May 9, 2022 OTC Link Quote Data
Attachment 23
Exhibit 23- May 10, 2022 OTC Link Quote Data Part 1
Attachment 24
Exhibit 24- May 10, 2022 OTC Link Quote Data Part 2
Attachment 25
Exhibit 25- May 10, 2022 OTC Link Quote Data Part 3
Attachment 26
Exhibit 26- May 10, 2022 OTC Link Quote Data Part 4
Attachment 27
Exhibit 27- May 10, 2022 OTC Link Quote Data Part 5
Attachment 28
Exhibit 28- May 10, 2022 OTC Link Trade Data
115
Jul 12, 2023
MEMORANDUM OF LAW in Support re: 114 MOTION to Dismiss Amended Complaint. . Document filed by Canaccord Genuity LLC, Citadel Securities LLC, G1 Execution Services LLC, GTS Securities LLC, Instinet LLC, Lime Trading Corp., Virtu Americas LLC..(Burck, William) (Entered: 07/12/2023)
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Memorandum of Law in Support of Motion
114
Jul 12, 2023
MOTION to Dismiss Amended Complaint. Document filed by Canaccord Genuity LLC, Citadel Securities LLC, G1 Execution Services LLC, GTS Securities LLC, Instinet LLC, Lime Trading Corp., Virtu Americas LLC..(Burck, William) (Entered: 07/12/2023)
Main Document
Motion to Dismiss
113
Jun 15, 2023
MEMO ENDORSEMENT: on re: 110 Letter filed by Citadel Securities LLC. ENDORSEMENT: The Court understands that the defendant will be moving to dismiss the pleading that is the subject of the proposed Rule 11 motion. In order not to burden the Court with multiple motions addressed to the same pleading, we direct that the Rule 11 motion be filed, if at all, following disposition of the motion to dismiss the Amended Complaint. SO ORDERED. (Signed by Magistrate Judge Gabriel W. Gorenstein on 6/15/2023) (ama) (Entered: 06/15/2023)
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Memo Endorsement
112
Jun 14, 2023
LETTER addressed to Magistrate Judge Gabriel W. Gorenstein from William A. Burck dated June 14, 2023 re: Plaintiff's June 14, 2023 letter. Document filed by Citadel Securities LLC..(Burck, William) (Entered: 06/14/2023)
Main Document
Letter
111
Jun 14, 2023
LETTER addressed to Judge Gregory H. Woods from Laura H. Posner dated June 14, 2023 re: Anticipated Def. Citadel Securities LLC motion for Rule 11 sanctions. Document filed by Northwest Biotherapeutics, Inc.. (Attachments: # 1 Exhibit 1).(Posner, Laura) (Entered: 06/14/2023)
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Letter
Attachment 1
Exhibit 1
110
Jun 12, 2023
LETTER addressed to Magistrate Judge Gabriel W. Gorenstein from William A. Burck dated June 12, 2023 re: request for pre-motion conference regarding Citadel Securities' anticipated motion for Rule 11 sanctions. Document filed by Citadel Securities LLC..(Burck, William) (Entered: 06/12/2023)
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Letter
109
Jun 6, 2023
MEMO ENDORSEMENT: on re: 108 Letter filed by G1 Execution Services LLC, Lime Trading Corp., Virtu Americas LLC, GTS Securities LLC, Citadel Securities LLC, Canaccord Genuity LLC, Instinet LLC. ENDORSEMENT: The proposed revision to the briefing schedule is approved. SO ORDERED., ( Motions due by 7/12/2023., Responses due by 8/25/2023, Replies due by 9/27/2023.) (Signed by Magistrate Judge Gabriel W. Gorenstein on 6/06/2023) (ama) (Entered: 06/06/2023)
Main Document
Memo Endorsement
108
Jun 6, 2023
LETTER addressed to Magistrate Judge Gabriel W. Gorenstein from William A. Burck dated June 6, 2023 re: extension of the briefing deadlines for Defendants' motion to dismiss. Document filed by Canaccord Genuity LLC, Citadel Securities LLC, G1 Execution Services LLC, GTS Securities LLC, Instinet LLC, Lime Trading Corp., Virtu Americas LLC..(Burck, William) (Entered: 06/06/2023)
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Letter
107
May 31, 2023
NOTICE OF APPEARANCE by Raymond Michael Sarola on behalf of Northwest Biotherapeutics, Inc...(Sarola, Raymond) (Entered: 05/31/2023)
Main Document
Notice of Appearance
106
May 31, 2023
ORDER: The Court is in receipt of a letter from plaintiff (Docket # 102) submitting a corrected Exhibit 1 (Docket # 102-1) meant to substitute for the Exhibit 1 to the First Amended Complaint (Docket # 95-1). We have considered the defendants' opposition. See Docket ## 103 & 104. Because the errors to theoriginal Exhibit 1 were due only to a "ministerial transcription error caused in converting an Excel file into a Word file for filing" (Docket # 105 at 1), because there has been no suggestion of any prejudice from the amendment (other than the need to file a motion to dismiss, whose deadline the Court will extend should the defendants request it), and because Fed. R. Civ. P. 15 requires that leave to amend be "freely give[n]," the revised Exhibit 1 (Docket # 102-1) is deemed to replace the current Exhibit 1 (Docket # 95-1). SO ORDERED. (Signed by Magistrate Judge Gabriel W. Gorenstein on 5/31/2023) (ama) (Entered: 05/31/2023)
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Order
105
May 26, 2023
LETTER addressed to Judge Gregory H. Woods from Laura H. Posner dated May 26, 2023 re: Defendants' May 26, 2023 Letters (ECF No. 103 & 104). Document filed by Northwest Biotherapeutics, Inc...(Posner, Laura) (Entered: 05/26/2023)
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Letter
104
May 26, 2023
LETTER addressed to Judge Gregory H. Woods from Marjorie J. Peerce dated May 26, 2023 re: Plaintiff's May 25, 2023 Letter (ECF No. 102). Document filed by G1 Execution Services LLC..(Peerce, Marjorie) (Entered: 05/26/2023)
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Letter
103
May 26, 2023
LETTER addressed to Judge Gregory H. Woods from William A. Burck dated May 26, 2023 re: Plaintiff's May 25, 2023 Letter 102 . Document filed by Canaccord Genuity LLC, Citadel Securities LLC, GTS Securities LLC, Lime Trading Corp., Virtu Americas LLC..(Burck, William) (Entered: 05/26/2023)
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Letter
102
May 25, 2023
LETTER addressed to Judge Gregory H. Woods from Laura H. Posner dated May 25, 2023 re: Corrected Exhibit 1 to Amended Complaint ECF No. 95. Document filed by Northwest Biotherapeutics, Inc.. (Attachments: # 1 Exhibit 1).(Posner, Laura) (Entered: 05/25/2023)
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Letter
Attachment 1
Exhibit 1
101
May 8, 2023
ORDER GRANTING MOTION TO WITHDRAW AS COUNSEL granting 100 Motion to Withdraw as Attorney. IT IS HEREBY ORDERED that Plaintiff's Motion to Withdraw Jessica (Ji Eun) Kim as counsel in the above-captioned matter is GRANTED. The Clerk of Court is directed to terminate Ms. Kim from the list of active counsel in this case. Attorney Ji Eun Kim terminated. (Signed by Magistrate Judge Gabriel W. Gorenstein on 5/8/2023) (kv) (Entered: 05/08/2023)
Main Document
Order on Motion to Withdraw as Attorney
100
May 5, 2023
MOTION for Jessica (Ji Eun) Kim to Withdraw as Attorney . Document filed by Northwest Biotherapeutics, Inc.. (Attachments: # 1 Text of Proposed Order A).(Kim, Ji Eun) (Entered: 05/05/2023)
Main Document
Motion to Withdraw as Attorney
Attachment 1
Text of Proposed Order A
99
May 1, 2023
ORDER granting 98 Letter Motion for Leave to File Excess Pages. The proposals regarding the briefing schedule and page limitations as stated in this letter are approved. (Signed by Magistrate Judge Gabriel W. Gorenstein on 5/1/2023) (rro) (Entered: 05/01/2023)
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Order on Motion for Leave to File Excess Pages
98
Apr 28, 2023
LETTER MOTION for Leave to File Excess Pages and Set a Briefing Schedule for Defendants' Motion to Dismiss the Amended Complaint addressed to Magistrate Judge Gabriel W. Gorenstein from William Burck dated April 28, 2023. Document filed by Canaccord Genuity LLC, Citadel Securities LLC, G1 Execution Services LLC, GTS Securities LLC, Instinet LLC, Lime Trading Corp., Virtu Americas LLC..(Burck, William) (Entered: 04/28/2023)
Main Document
Motion for Leave to File Excess Pages
97
Apr 11, 2023
ORDER: withdrawing 85 Motion to Dismiss; withdrawing 87 Motion to Dismiss; withdrawing 90 Motion to Dismiss. In light of the filing of the amended complaint, the pending motions to dismiss the original complaint (Docket ## 85, 87 and 90) are moot and thus are deemed withdrawn. SO ORDERED. (Signed by Magistrate Judge Gabriel W. Gorenstein on 4/11/2023) (ama) (Entered: 04/11/2023)
Main Document
Order on Motion to Dismiss
96
Apr 10, 2023
LETTER addressed to Judge Gregory H. Woods from Laura H. Posner dated April 10, 2023 re: Attaching Blacklined Amended Complaint. Document filed by Northwest Biotherapeutics, Inc.. (Attachments: # 1 Exhibit Attachment - Blacklined Amended Complaint).(Posner, Laura) (Entered: 04/10/2023)
Main Document
Letter
Attachment 1
Exhibit Attachment - Blacklined Amended Complaint
95
Apr 10, 2023
AMENDED COMPLAINT amending 1 Complaint, against Canaccord Genuity LLC, Citadel Securities LLC, G1 Execution Services LLC, GTS Securities LLC, Instinet LLC, Lime Trading Corp., Virtu Americas LLC with JURY DEMAND.Document filed by Northwest Biotherapeutics, Inc.. Related document: 1 Complaint,. (Attachments: # 1 Exhibit 1, # 2 Exhibit 2).(Posner, Laura) (Entered: 04/10/2023)
Main Document
Amended Complaint
Attachment 1
Exhibit 1
Attachment 2
Exhibit 2
94
Mar 29, 2023
ORDER FOR ADMISSION PRO HAC VICE granting 92 Motion for Christopher G. Michel to Appear Pro Hac Vice. (Signed by Magistrate Judge Gabriel W. Gorenstein on 3/29/2023) (vfr) (Entered: 03/29/2023)
Main Document
Order on Motion to Appear Pro Hac Vice
Mar 28, 2023
>>>NOTICE REGARDING PRO HAC VICE MOTION. Regarding Document No. 92 AMENDED MOTION for Christopher G. Michel to Appear Pro Hac Vice . Motion and supporting papers to be reviewed by Clerk's Office staff.. The document has been reviewed and there are no deficiencies. (aea)
Notice Regarding Pro Hac Vice Motion
93
Mar 27, 2023
LETTER addressed to Judge Gregory H. Woods from Laura H. Posner dated March 27, 2023 re: Amending Complaint. Document filed by Northwest Biotherapeutics, Inc...(Posner, Laura) (Entered: 03/27/2023)
Main Document
Letter
92
Mar 27, 2023
AMENDED MOTION for Christopher G. Michel to Appear Pro Hac Vice . Motion and supporting papers to be reviewed by Clerk's Office staff. Document filed by Citadel Securities LLC. (Attachments: # 1 Affidavit /Declaration of Christopher G. Michel, # 2 Exhibit A - Certificate of Good Standing - Virginia, # 3 Exhibit B - Certificate of Good Standing - DC, # 4 Text of Proposed Order for Admission Pro Hac Vice).(Michel, Christopher) (Entered: 03/27/2023)
Main Document
Motion to Appear Pro Hac Vice
Attachment 1
Affidavit /Declaration of Christopher G. Michel
Attachment 2
Exhibit A - Certificate of Good Standing - Virginia
Attachment 3
Exhibit B - Certificate of Good Standing - DC
Attachment 4
Text of Proposed Order for Admission Pro Hac Vice
91
Mar 20, 2023
MEMORANDUM OF LAW in Support re: 85 MOTION to Dismiss ., 90 MOTION to Dismiss . . Document filed by Canaccord Genuity LLC..(Fiotto, Anthony) (Entered: 03/20/2023)
Main Document
Memorandum of Law in Support of Motion
90
Mar 20, 2023
MOTION to Dismiss . Document filed by Canaccord Genuity LLC. Responses due by 5/4/2023.(Fiotto, Anthony) (Entered: 03/20/2023)
Main Document
Motion to Dismiss
89
Mar 20, 2023
MEMORANDUM OF LAW in Support re: 87 MOTION to Dismiss . . Document filed by G1 Execution Services LLC, Susquehanna International Group, LLP..(Peerce, Marjorie) (Entered: 03/20/2023)
Main Document
Memorandum of Law in Support of Motion
88
Mar 20, 2023
DECLARATION of William A. Burck in Support re: 85 MOTION to Dismiss .. Document filed by Citadel Securities LLC. (Attachments: # 1 Exhibit 1 - NWBO Stock Price, # 2 Exhibit 2 - Over-the-Counter Market, # 3 Exhibit 3 - OTC Link FIX Quotation Service, # 4 Exhibit 4 - NWBO SEC Order (October 10, 2019), # 5 Exhibit 5 - STAT Article (May 10, 2022), # 6 Exhibit 6 - OTC Markets Broker-Dealer Directory, # 7 Exhibit 7 - NWBO 2019 Form 10-K, # 8 Exhibit 8 - NWBO 2020 Form 10-K).(Burck, William) (Entered: 03/20/2023)
Main Document
Declaration in Support of Motion
Attachment 1
Exhibit 1 - NWBO Stock Price
Attachment 2
Exhibit 2 - Over-the-Counter Market
Attachment 3
Exhibit 3 - OTC Link FIX Quotation Service
Attachment 4
Exhibit 4 - NWBO SEC Order (October 10, 2019)
Attachment 5
Exhibit 5 - STAT Article (May 10, 2022)
Attachment 6
Exhibit 6 - OTC Markets Broker-Dealer Directory
Attachment 7
Exhibit 7 - NWBO 2019 Form 10-K
Attachment 8
Exhibit 8 - NWBO 2020 Form 10-K
87
Mar 20, 2023
MOTION to Dismiss . Document filed by G1 Execution Services LLC, Susquehanna International Group, LLP..(Peerce, Marjorie) (Entered: 03/20/2023)
Main Document
Motion to Dismiss
86
Mar 20, 2023
MEMORANDUM OF LAW in Support re: 85 MOTION to Dismiss . (Defendants' Joint Memorandum of Law In Support Of Motion To Dismiss). Document filed by Canaccord Genuity LLC, Citadel Securities LLC, G1 Execution Services LLC, GTS Securities LLC, Instinet LLC, Lime Trading Corp., Susquehanna International Group, LLP, Virtu Americas LLC..(Burck, William) (Entered: 03/20/2023)
Main Document
Memorandum of Law in Support of Motion
85
Mar 20, 2023
MOTION to Dismiss . Document filed by Canaccord Genuity LLC, Citadel Securities LLC, G1 Execution Services LLC, GTS Securities LLC, Instinet LLC, Lime Trading Corp., Susquehanna International Group, LLP, Virtu Americas LLC..(Burck, William) (Entered: 03/20/2023)
Main Document
Motion to Dismiss
Mar 20, 2023
Notice Regarding Deficient Motion to Appear Pro Hac Vice
Mar 20, 2023
>>>NOTICE REGARDING DEFICIENT MOTION TO APPEAR PRO HAC VICE. Notice to RE-FILE Document No. 84 MOTION for Christopher G. Michel to Appear Pro Hac Vice . Filing fee $ 200.00, receipt number ANYSDC-27486223. Motion and supporting papers to be reviewed by Clerk's Office staff. The filing is deficient for the following reason(s): missing Certificate of Good Standing from Supreme Court of Virginia (NOT State Bar). Re-file the motion as a Motion to Appear Pro Hac Vice - attach the correct signed PDF - select the correct named filer/filers - attach valid Certificates of Good Standing issued within the past 30 days - attach Proposed Order. (aea)
Notice Regarding Deficient Motion to Appear Pro Hac vice
84
Mar 17, 2023
FILING ERROR - DEFICIENT DOCKET ENTRY - MOTION for Christopher G. Michel to Appear Pro Hac Vice . Filing fee $ 200.00, receipt number ANYSDC-27486223. Motion and supporting papers to be reviewed by Clerk's Office staff. Document filed by Citadel Securities LLC. (Attachments: # 1 Affidavit /Declaration of Christopher G. Michel, # 2 Exhibit A - Certificate of Good Standing, # 3 Exhibit B - Certificate of Good Standing, # 4 Text of Proposed Order for Admission Pro Hac Vice).(Michel, Christopher) Modified on 3/20/2023 (aea). (Entered: 03/17/2023)
Main Document
Motion to Appear Pro Hac Vice
Attachment 1
Affidavit /Declaration of Christopher G. Michel
Attachment 2
Exhibit A - Certificate of Good Standing
Attachment 3
Exhibit B - Certificate of Good Standing
Attachment 4
Text of Proposed Order for Admission Pro Hac Vice
Mar 16, 2023
Set/Reset Deadlines: Motions due by 3/20/2023. Responses due by 5/4/2023 Replies due by 6/5/2023. (tg)
Set/Reset Deadlines
83
Mar 16, 2023
ORDER granting 80 Letter Motion for Leave to File Excess Pages. The proposal as to the briefing schedule and page limitations is approved. So Ordered. (Signed by Magistrate Judge Gabriel W. Gorenstein on 3/16/2023) (tg) (Entered: 03/16/2023)
Main Document
Order on Motion for Leave to File Excess Pages
82
Mar 15, 2023
NOTICE OF APPEARANCE by Peter Hall Fountain on behalf of Citadel Securities LLC..(Fountain, Peter) (Entered: 03/15/2023)
Main Document
Notice of Appearance
81
Mar 15, 2023
NOTICE OF APPEARANCE by Brenna D Nelinson on behalf of Citadel Securities LLC..(Nelinson, Brenna) (Entered: 03/15/2023)
Main Document
Notice of Appearance
80
Mar 15, 2023
LETTER MOTION for Leave to File Excess Pages addressed to Magistrate Judge Gabriel W. Gorenstein from William Burck dated March 15, 2023. Document filed by Citadel Securities LLC..(Burck, William) (Entered: 03/15/2023)
Main Document
Motion for Leave to File Excess Pages
Feb 28, 2023
Set/Reset Deadlines: Canaccord Genuity LLC answer due 4/5/2023; Citadel Securities LLC answer due 4/5/2023; G1 Execution Services LLC answer due 4/5/2023; GTS Securities LLC answer due 4/5/2023; Instinet LLC answer due 4/5/2023; Lime Trading Corp. answer due 4/5/2023; Susquehanna International Group, LLP answer due 4/5/2023; Virtu Americas LLC answer due 4/5/2023. (ama)
Feb 28, 2023
Set/Reset Deadlines: Canaccord Genuity LLC answer due 3/20/2023; Citadel Securities LLC answer due 3/20/2023; G1 Execution Services LLC answer due 3/20/2023; GTS Securities LLC answer due 3/20/2023; Instinet LLC answer due 3/20/2023; Lime Trading Corp. answer due 3/20/2023; Susquehanna International Group, LLP answer due 3/20/2023; Virtu Americas LLC answer due 3/20/2023. (ama)
Set/Reset Deadlines
79
Feb 28, 2023
ORDER: granting in part and denying in part 77 Letter Motion for Extension of Time to File. Granted in part and denied in part. In light of plaintiff's response, an extension is granted only until March 20, 2023. If both parties agree to a further extension, it may be requested by means of a letter compliant with paragraph 1.E of the Court's Individual Practices. On a separate point,the Court wishes to be sure that the memoranda of law are properly focused. Accordingly, the parties shall be limited to 25 pages for any moving and opposition brief and to 15 pages for any reply brief. SO ORDERED. (Signed by Magistrate Judge Gabriel W. Gorenstein on 2/28/2023) (ama) (Entered: 02/28/2023)
Main Document
Order on Motion for Extension of Time to File
78
Feb 28, 2023
LETTER addressed to Magistrate Judge Gabriel W. Gorenstein from Laura H. Posner dated February 28, 2023 re: in response to Defendant's February 27, 2023 letter 77 . Document filed by Northwest Biotherapeutics, Inc.. (Attachments: # 1 Exhibit A, # 2 Exhibit B, # 3 Exhibit C, # 4 Exhibit D, # 5 Exhibit E, # 6 Exhibit F).(Posner, Laura) (Entered: 02/28/2023)
Main Document
Letter
Attachment 1
Exhibit A
Attachment 2
Exhibit B
Attachment 3
Exhibit C
Attachment 4
Exhibit D
Attachment 5
Exhibit E
Attachment 6
Exhibit F
77
Feb 27, 2023
LETTER MOTION for Extension of Time to File Response to Complaint addressed to Magistrate Judge Gabriel W. Gorenstein from William Burck dated February 27, 2023. Document filed by Citadel Securities LLC. (Attachments: # 1 Exhibit A - 2023.02.26 Letter from W. Burck).(Burck, William) (Entered: 02/27/2023)
Main Document
Motion for Extension of Time to File
Attachment 1
Exhibit A - 2023.02.26 Letter from W. Burck
76
Feb 9, 2023
NOTICE OF APPEARANCE by Jesse Bernstein on behalf of Citadel Securities LLC..(Bernstein, Jesse) (Entered: 02/09/2023)
Main Document
Notice of Appearance
75
Jan 20, 2023
LETTER addressed to Magistrate Judge Gabriel W. Gorenstein from Laura H. Posner dated January 20, 2023 re: Plaintiff's Response per December 20, 2022 Order. Document filed by Northwest Biotherapeutics, Inc...(Posner, Laura) (Entered: 01/20/2023)
Main Document
Letter
74
Jan 20, 2023
ORDER: With regard to the motions proposed in Docket ## 69 and 70, the Court's pre-motion conference requirement is waived. The motions shall be filed on or before March 6, 2023. Briefing thereafter shall be in accordance with paragraph 2.B of the Court's Individual Practices. SO ORDERED., ( Motions due by 3/6/2023.) (Signed by Magistrate Judge Gabriel W. Gorenstein on 1/20/2023) (ama) (Entered: 01/20/2023)
Main Document
Order
73
Jan 18, 2023
NOTICE OF APPEARANCE by Elizabeth H. Lindh on behalf of Lime Trading Corp...(Lindh, Elizabeth) (Entered: 01/18/2023)
Main Document
Notice of Appearance
72
Jan 17, 2023
ORDER FOR ADMISSION PRO HAC VICE: granting 62 Motion for Elizabeth H. Lindh to Appear Pro Hac Vice. (Signed by Magistrate Judge Gabriel W. Gorenstein on 1/17/2023) (ama) (Entered: 01/17/2023)
Main Document
Order on Motion to Appear Pro Hac Vice
71
Jan 17, 2023
ORDER FOR ADMISSION PRO HAC VICE: granting 61 Motion for Leigh A. Brissenden to Appear Pro Hac Vice. (Signed by Magistrate Judge Gabriel W. Gorenstein on 1/17/2023) (ama) (Entered: 01/17/2023)
Main Document
Order on Motion to Appear Pro Hac Vice
70
Jan 13, 2023
LETTER addressed to Magistrate Judge Gabriel W. Gorenstein from Stephen Young dated January 13, 2023 re: compliance with the Court's December 20, 2022 Order and Judge Gorenstein's Individual Practices Rule 2(A). Document filed by Lime Trading Corp...(Young, Stephen) (Entered: 01/13/2023)
Main Document
Letter
69
Jan 13, 2023
LETTER addressed to Magistrate Judge Gabriel W. Gorenstein from William Burck dated January 13, 2023 re: Pre-Motion Letter to Court. Document filed by Citadel Securities LLC..(Burck, William) (Entered: 01/13/2023)
Main Document
Letter
68
Jan 13, 2023
RULE 7.1 CORPORATE DISCLOSURE STATEMENT. Identifying Corporate Parent Nomura Holdings, Inc., Corporate Parent Nomura Holding America Inc., Corporate Parent Instinet Holdings Incorporated, Corporate Parent Instinet Incorporated for Instinet LLC. Document filed by Instinet LLC..(Filor, Daniel) (Entered: 01/13/2023)
Main Document
Rule 7.1 Corporate Disclosure Statement
67
Jan 13, 2023
NOTICE OF APPEARANCE by John Chesley Burruss on behalf of G1 Execution Services LLC, Susquehanna International Group, LLP..(Burruss, John) (Entered: 01/13/2023)
Main Document
Notice of Appearance
66
Jan 13, 2023
RULE 7.1 CORPORATE DISCLOSURE STATEMENT. Identifying Corporate Parent G1X Holdings, LLC for G1 Execution Services LLC. Document filed by G1 Execution Services LLC, Susquehanna International Group, LLP..(Peerce, Marjorie) (Entered: 01/13/2023)
Main Document
Rule 7.1 Corporate Disclosure Statement
65
Jan 13, 2023
NOTICE OF APPEARANCE by Marjorie Joan Peerce on behalf of G1 Execution Services LLC, Susquehanna International Group, LLP..(Peerce, Marjorie) (Entered: 01/13/2023)
Main Document
Notice of Appearance
64
Jan 12, 2023
ORDER FOR ADMISSION PRO HAC VICE: granting 63 Motion for Hannah O. Koesterer to Appear Pro Hac Vice. (Signed by Magistrate Judge Gabriel W. Gorenstein on 1/12/2023) (ama) (Entered: 01/12/2023)
Main Document
Order on Motion to Appear Pro Hac Vice
Jan 11, 2023
>>>NOTICE REGARDING PRO HAC VICE MOTION. Regarding Document No. 61 MOTION for Leigh A. Brissenden to Appear Pro Hac Vice . Filing fee $ 200.00, receipt number ANYSDC-27185057. Motion and supporting papers to be reviewed by Clerk's Office staff., 62 MOTION for Elizabeth H. Lindh to Appear Pro Hac Vice . Filing fee $ 200.00, receipt number ANYSDC-27185399. Motion and supporting papers to be reviewed by Clerk's Office staff., 63 MOTION for Hannah O. Koesterer to Appear Pro Hac Vice . Filing fee $ 200.00, receipt number ANYSDC-27189790. Motion and supporting papers to be reviewed by Clerk's Office staff.. The document has been reviewed and there are no deficiencies. (sac)
Notice Regarding Pro Hac Vice Motion
63
Jan 11, 2023
MOTION for Hannah O. Koesterer to Appear Pro Hac Vice . Filing fee $ 200.00, receipt number ANYSDC-27189790. Motion and supporting papers to be reviewed by Clerk's Office staff. Document filed by GTS Securities LLC. (Attachments: # 1 Affidavit Of Hannah O. Koesterer In Support; With Certificate Of Good Standing, # 2 Text of Proposed Order For Admission Pro Hac Vice).(Koesterer, Hannah) (Entered: 01/11/2023)
Main Document
Motion to Appear Pro Hac Vice
Attachment 1
Affidavit Of Hannah O. Koesterer In Support; With Certificate Of Good Standing
Attachment 2
Text of Proposed Order For Admission Pro Hac Vice
62
Jan 10, 2023
MOTION for Elizabeth H. Lindh to Appear Pro Hac Vice . Filing fee $ 200.00, receipt number ANYSDC-27185399. Motion and supporting papers to be reviewed by Clerk's Office staff. Document filed by Lime Trading Corp.. (Attachments: # 1 Affidavit Affidavit of Elizabeth H. Lindh ISO of Motion to Admit Counsel Pro Hac Vice, # 2 Text of Proposed Order (Proposed) Order for Admission Pro Hac Vice).(Lindh, Elizabeth) (Entered: 01/10/2023)
Main Document
Motion to Appear Pro Hac Vice
Attachment 1
Affidavit Affidavit of Elizabeth H. Lindh ISO of Motion to Admit Counsel Pro Hac
Attachment 2
Text of Proposed Order (Proposed) Order for Admission Pro Hac Vice
61
Jan 10, 2023
MOTION for Leigh A. Brissenden to Appear Pro Hac Vice . Filing fee $ 200.00, receipt number ANYSDC-27185057. Motion and supporting papers to be reviewed by Clerk's Office staff. Document filed by GTS Securities LLC. (Attachments: # 1 Affidavit Of Leigh A. Brissenden In Support; With Certificate Of Good Standing, # 2 Text of Proposed Order For Admission Pro Hac Vice).(Brissenden, Leigh) (Entered: 01/10/2023)
Main Document
Motion to Appear Pro Hac Vice
Attachment 1
Affidavit Of Leigh A. Brissenden In Support; With Certificate Of Good Standing
Attachment 2
Text of Proposed Order For Admission Pro Hac Vice
60
Jan 10, 2023
ORDER FOR ADMISSION PRO HAC VICE: granting 59 Motion for Christian T. Kemnitz to Appear Pro Hac Vice. (Signed by Magistrate Judge Gabriel W. Gorenstein on 1/10/2023) (ama) Modified on 1/10/2023 (ama). (Entered: 01/10/2023)
Main Document
Order on Motion to Appear Pro Hac Vice
Jan 9, 2023
>>>NOTICE REGARDING PRO HAC VICE MOTION. Regarding Document No. 59 MOTION for Christian T. Kemnitz to Appear Pro Hac Vice . Filing fee $ 200.00, receipt number ANYSDC-27172133. Motion and supporting papers to be reviewed by Clerk's Office staff.. The document has been reviewed and there are no deficiencies. (sgz)
Notice Regarding Pro Hac Vice Motion
59
Jan 6, 2023
MOTION for Christian T. Kemnitz to Appear Pro Hac Vice . Filing fee $ 200.00, receipt number ANYSDC-27172133. Motion and supporting papers to be reviewed by Clerk's Office staff. Document filed by GTS Securities LLC. (Attachments: # 1 Affidavit Of Christian T. Kemnitz In Support; With Certificate Of Good Standing, # 2 Text of Proposed Order For Admission Pro Hac Vice).(Kemnitz, Christian) (Entered: 01/06/2023)
Main Document
Motion to Appear Pro Hac Vice
Attachment 1
Affidavit Of Christian T. Kemnitz In Support; With Certificate Of Good Standing
Attachment 2
Text of Proposed Order For Admission Pro Hac Vice
Jan 3, 2023
Order on Motion to Appear Pro Hac Vice
58
Jan 3, 2023
ORDER granting 57 Motion for Stephen Young to Appear Pro Hac Vice. (HEREBY ORDERED by Judge Gregory H. Woods)(Text Only Order) (wv) (Entered: 01/03/2023)
Main Document
Order on Motion to Appear Pro Hac Vice
Dec 30, 2022
>>>NOTICE REGARDING PRO HAC VICE MOTION. Regarding Document No. 57 MOTION for Stephen Young to Appear Pro Hac Vice . Motion and supporting papers to be reviewed by Clerk's Office staff.. The document has been reviewed and there are no deficiencies. (sgz)
Notice Regarding Pro Hac Vice Motion
Dec 29, 2022
Notice Regarding Deficient Motion to Appear Pro Hac Vice
57
Dec 29, 2022
MOTION for Stephen Young to Appear Pro Hac Vice . Motion and supporting papers to be reviewed by Clerk's Office staff. Document filed by Lime Trading Corp.. (Attachments: # 1 Affidavit of Stephen Young In Support of Motion to Admit Counsel Pro Hac Vice, # 2 Text of Proposed Order Proposed Order for Admission Pro Hac Vice).(Young, Stephen) (Entered: 12/29/2022)
Main Document
Motion to Appear Pro Hac Vice
Attachment 1
Affidavit of Stephen Young In Support of Motion to Admit Counsel Pro Hac Vice
Attachment 2
Text of Proposed Order Proposed Order for Admission Pro Hac Vice
Dec 29, 2022
>>>NOTICE REGARDING DEFICIENT MOTION TO APPEAR PRO HAC VICE. Notice to RE-FILE Document No. 56 MOTION for Stephen Young to Appear Pro Hac Vice . Filing fee $ 200.00, receipt number ANYSDC-27140187. Motion and supporting papers to be reviewed by Clerk's Office staff... The filing is deficient for the following reason(s): Affidavit Not Notarized;. Re-file the motion as a Motion to Appear Pro Hac Vice - attach the correct signed PDF - select the correct named filer/filers - attach valid Certificates of Good Standing issued within the past 30 days - attach Proposed Order. (sgz)
Notice Regarding Deficient Motion to Appear Pro Hac vice
56
Dec 28, 2022
FILING ERROR - DEFICIENT DOCKET ENTRY - MOTION for Stephen Young to Appear Pro Hac Vice . Filing fee $ 200.00, receipt number ANYSDC-27140187. Motion and supporting papers to be reviewed by Clerk's Office staff. Document filed by Lime Trading Corp.. (Attachments: # 1 Affidavit Verified Statement & Certificate of Good Standing, # 2 Text of Proposed Order Proposed Order Granting Appearance as Pro Hac Vice Counsel).(Young, Stephen) Modified on 12/29/2022 (sgz). (Entered: 12/28/2022)
Main Document
Motion to Appear Pro Hac Vice
Attachment 1
Affidavit Verified Statement & Certificate of Good Standing
Attachment 2
Text of Proposed Order Proposed Order Granting Appearance as Pro Hac Vice Counse
55
Dec 20, 2022
RULE 7.1 CORPORATE DISCLOSURE STATEMENT. Identifying Corporate Parent FH Global, Inc., Other Affiliate Victor Remsha for Lime Trading Corp.. Document filed by Lime Trading Corp...(Young, Stephen) (Entered: 12/20/2022)
Main Document
Rule 7.1 Corporate Disclosure Statement
54
Dec 20, 2022
NOTICE OF APPEARANCE by Stephen Young on behalf of Lime Trading Corp...(Young, Stephen) (Entered: 12/20/2022)
Main Document
Notice of Appearance
53
Dec 20, 2022
SUMMONS RETURNED EXECUTED. Citadel Securities LLC served on 12/6/2022, answer due 1/13/2023. Document filed by Northwest Biotherapeutics, Inc...(Posner, Laura) (Entered: 12/20/2022)
Main Document
Summons Returned Executed
52
Dec 20, 2022
NOTICE OF APPEARANCE by Daniel R. Koffmann on behalf of Citadel Securities LLC..(Koffmann, Daniel) (Entered: 12/20/2022)
Main Document
Notice of Appearance
51
Dec 20, 2022
SUMMONS RETURNED EXECUTED. G1 Execution Services LLC served on 12/6/2022, answer due 1/13/2023. Document filed by Northwest Biotherapeutics, Inc...(Posner, Laura) (Entered: 12/20/2022)
Main Document
Summons Returned Executed
50
Dec 20, 2022
SUMMONS RETURNED EXECUTED. Instinet LLC served on 12/7/2022, answer due 1/13/2023. Document filed by Northwest Biotherapeutics, Inc...(Posner, Laura) (Entered: 12/20/2022)
Main Document
Summons Returned Executed
49
Dec 20, 2022
NOTICE OF APPEARANCE by Christopher Daniel Kercher on behalf of Citadel Securities LLC..(Kercher, Christopher) (Entered: 12/20/2022)
Main Document
Notice of Appearance
48
Dec 20, 2022
NOTICE OF APPEARANCE by Leigha Empson on behalf of Citadel Securities LLC..(Empson, Leigha) (Entered: 12/20/2022)
Main Document
Notice of Appearance
47
Dec 20, 2022
NOTICE OF APPEARANCE by Brendan Thomas Carroll on behalf of Citadel Securities LLC..(Carroll, Brendan) (Entered: 12/20/2022)
Main Document
Notice of Appearance
46
Dec 20, 2022
RULE 7.1 CORPORATE DISCLOSURE STATEMENT. Identifying Corporate Parent Citadel Securities GP LLC for Citadel Securities LLC. Document filed by Citadel Securities LLC..(Burck, William) (Entered: 12/20/2022)
Main Document
Rule 7.1 Corporate Disclosure Statement
45
Dec 20, 2022
NOTICE OF APPEARANCE by William Anthony Burck on behalf of Citadel Securities LLC..(Burck, William) (Entered: 12/20/2022)
Main Document
Notice of Appearance
Dec 20, 2022
Set/Reset Deadlines: Canaccord Genuity LLC answer due 1/13/2023; Citadel Securities LLC answer due 1/13/2023; G1 Execution Services LLC answer due 1/13/2023; GTS Securities LLC answer due 1/13/2023; Instinet LLC answer due 1/13/2023; Lime Trading Corp. answer due 1/13/2023; Susquehanna International Group, LLP answer due 1/13/2023; Virtu Americas LLC answer due 1/13/2023. (ama)
Set/Reset Deadlines
44
Dec 20, 2022
ORDER: granting in part 43 Letter Motion for Extension of Time. Application granted in part. Plaintiff shall file all affidavits of service by January 6, 2023. The time for a served defendant to respond to the complaint is extended to January 13, 2023, or the date provided in Fed. R. Civ. P. 12(a)(1)(A), whichever is later for that defendant. A defendant planning to move to dismiss may satisfy its obligation to respond by filing a letter on the date required for its response that requests permission to file such a motion. In any such letter, the defendant may propose a briefing schedule. Plaintiff shall respond to any letter requesting permission to file a motion to dismiss within 7 days thereafter. If a request for permission to file a motion to dismiss is denied for any defendant, that defendant's answer shall be due 45 days after the denial. SO ORDERED. (Signed by Magistrate Judge Gabriel W. Gorenstein on 12/20/2022) (ama) (Entered: 12/20/2022)
Main Document
Order on Motion for Extension of Time
43
Dec 19, 2022
CONSENT LETTER MOTION for Extension of Time for all Defendants to file pre-motion letters to dismiss with proposed briefing schedule addressed to Magistrate Judge Gabriel W. Gorenstein from Anthony S. Fiotto dated December 19, 2022. Document filed by Canaccord Genuity LLC..(Fiotto, Anthony) (Entered: 12/19/2022)
Main Document
Motion for Extension of Time
42
Dec 16, 2022
RULE 7.1 CORPORATE DISCLOSURE STATEMENT. Identifying Corporate Parent Virtu Financial, Inc. for Virtu Americas LLC. Document filed by Virtu Americas LLC..(Gordon, Andrew) (Entered: 12/16/2022)
Main Document
Rule 7.1 Corporate Disclosure Statement
41
Dec 16, 2022
NOTICE OF APPEARANCE by Daniel Shiah Sinnreich on behalf of Virtu Americas LLC..(Sinnreich, Daniel) (Entered: 12/16/2022)
Main Document
Notice of Appearance
40
Dec 16, 2022
NOTICE OF APPEARANCE by Jessica Sombat Carey on behalf of Virtu Americas LLC..(Carey, Jessica) (Entered: 12/16/2022)
Main Document
Notice of Appearance
39
Dec 16, 2022
NOTICE OF APPEARANCE by Audra Jan Soloway on behalf of Virtu Americas LLC..(Soloway, Audra) (Entered: 12/16/2022)
Main Document
Notice of Appearance
38
Dec 16, 2022
NOTICE OF APPEARANCE by Andrew Garry Gordon on behalf of Virtu Americas LLC..(Gordon, Andrew) (Entered: 12/16/2022)
Main Document
Notice of Appearance
37
Dec 13, 2022
SUMMONS RETURNED EXECUTED. Susquehanna International Group, LLP served on 12/6/2022, answer due 12/27/2022. Document filed by Northwest Biotherapeutics, Inc...(Posner, Laura) (Entered: 12/13/2022)
Main Document
Summons Returned Executed
36
Dec 12, 2022
RULE 7.1 CORPORATE DISCLOSURE STATEMENT. Identifying Corporate Parent GTS Financial LLC for GTS Securities LLC. Document filed by GTS Securities LLC..(Wilson, Peter) (Entered: 12/12/2022)
Main Document
Rule 7.1 Corporate Disclosure Statement
35
Dec 12, 2022
NOTICE OF APPEARANCE by Peter Ginewicz Wilson on behalf of GTS Securities LLC..(Wilson, Peter) (Entered: 12/12/2022)
Main Document
Notice of Appearance
34
Dec 9, 2022
NOTICE OF APPEARANCE by Nicholas Barnes on behalf of Instinet LLC..(Barnes, Nicholas) (Entered: 12/09/2022)
Main Document
Notice of Appearance
33
Dec 9, 2022
NOTICE OF APPEARANCE by Daniel Post Filor on behalf of Instinet LLC..(Filor, Daniel) (Entered: 12/09/2022)
Main Document
Notice of Appearance
32
Dec 9, 2022
NOTICE OF APPEARANCE by Richard Aframe Edlin on behalf of Instinet LLC..(Edlin, Richard) (Entered: 12/09/2022)
Main Document
Notice of Appearance
31
Dec 9, 2022
SUMMONS RETURNED EXECUTED. Virtu Americas LLC served on 12/5/2022, answer due 12/27/2022. Document filed by Northwest Biotherapeutics, Inc...(Posner, Laura) (Entered: 12/09/2022)
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Summons Returned Executed
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Dec 9, 2022
SUMMONS RETURNED EXECUTED. Canaccord Genuity LLC served on 12/5/2022, answer due 12/27/2022. Document filed by Northwest Biotherapeutics, Inc...(Posner, Laura) (Entered: 12/09/2022)
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Summons Returned Executed
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Dec 9, 2022
SUMMONS RETURNED EXECUTED. GTS Securities LLC served on 12/5/2022, answer due 12/27/2022. Document filed by Northwest Biotherapeutics, Inc...(Posner, Laura) (Entered: 12/09/2022)
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Dec 9, 2022
SUMMONS RETURNED EXECUTED. Lime Trading Corp. served on 12/5/2022, answer due 12/27/2022. Document filed by Northwest Biotherapeutics, Inc...(Posner, Laura) (Entered: 12/09/2022)
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Summons Returned Executed
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Dec 9, 2022
NOTICE OF APPEARANCE by Julia Catherine Koch on behalf of Canaccord Genuity LLC..(Koch, Julia) (Entered: 12/09/2022)
Main Document
Notice of Appearance
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Dec 9, 2022
NOTICE OF APPEARANCE by Eric Lawson on behalf of Canaccord Genuity LLC..(Lawson, Eric) (Entered: 12/09/2022)
Main Document
Notice of Appearance
25
Dec 9, 2022
NOTICE OF APPEARANCE by Anthony S. Fiotto, Jr on behalf of Canaccord Genuity LLC..(Fiotto, Anthony) (Entered: 12/09/2022)
Main Document
Notice of Appearance
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Dec 9, 2022
RULE 7.1 CORPORATE DISCLOSURE STATEMENT. Identifying Corporate Parent Collins Stewart Inc., Corporate Parent Canaccord Genuity Group Inc., Corporate Parent Canaccord Adams (Delaware) Inc., Corporate Parent Canaccord Adams Financial Group Inc. for Canaccord Genuity LLC. Document filed by Canaccord Genuity LLC..(Lawson, Eric) (Entered: 12/09/2022)
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Rule 7.1 Corporate Disclosure Statement
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Dec 6, 2022
ORDER REFERRING CASE TO MAGISTRATE JUDGE. Order that case be referred to the Clerk of Court for assignment to a Magistrate Judge for General Pretrial (includes scheduling, discovery, non-dispositive pretrial motions, and settlement) and Dispositive Motion (i.e., motion requiring a Report and Recommendation) and All such motions. Referred to Magistrate Judge Gabriel W. Gorenstein. (Signed by Judge Gregory H. Woods on 12/6/2022) (rro) (Entered: 12/06/2022)
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Order Referring Case to Magistrate Judge
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Dec 6, 2022
RULE 7.1 CORPORATE DISCLOSURE STATEMENT. No Corporate Parent. Document filed by Northwest Biotherapeutics, Inc...(Posner, Laura) (Entered: 12/06/2022)
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Rule 7.1 Corporate Disclosure Statement
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Dec 2, 2022
ELECTRONIC SUMMONS ISSUED as to Susquehanna International Group, LLP. (vf) (Entered: 12/02/2022)
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Summons Issued
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Dec 2, 2022
ELECTRONIC SUMMONS ISSUED as to Lime Trading Corp.. (vf) (Entered: 12/02/2022)
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Summons Issued
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Dec 2, 2022
REQUEST FOR ISSUANCE OF SUMMONS as to Susquehanna International Group LLP, re: 1 Complaint,. Document filed by Northwest Biotherapeutics, Inc...(Posner, Laura) (Entered: 12/02/2022)
Main Document
Request for Issuance of Summons
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Dec 2, 2022
REQUEST FOR ISSUANCE OF SUMMONS as to Lime Trading Corp., re: 1 Complaint,. Document filed by Northwest Biotherapeutics, Inc...(Posner, Laura) (Entered: 12/02/2022)
Main Document
Request for Issuance of Summons
Dec 2, 2022
***NOTICE TO ATTORNEY REGARDING DEFICIENT REQUEST FOR ISSUANCE OF SUMMONS. Notice to Attorney Laura Helen Posner to RE-FILE Document No 8 . The filing is deficient for the following reason(s): Defendant party name error. Defendant alias party name listed on Summons PDF does not correspond to pleading caption. Re-file the document using the event type Request for Issuance of Summons found under the event list Service of Process - select the correct filer/filers - and attach the correct summons form PDF. (vf) Modified on 12/2/2022 (vf).
17
Dec 2, 2022
ELECTRONIC SUMMONS ISSUED as to Virtu Americas LLC. (vf) (Entered: 12/02/2022)
Main Document
Summons Issued
16
Dec 2, 2022
ELECTRONIC SUMMONS ISSUED as to Instinet LLC. (vf) (Entered: 12/02/2022)
Main Document
Summons Issued
15
Dec 2, 2022
ELECTRONIC SUMMONS ISSUED as to GTS Securities LLC. (vf) (Entered: 12/02/2022)
Main Document
Summons Issued
14
Dec 2, 2022
ELECTRONIC SUMMONS ISSUED as to G1 Execution Services LLC. (vf) (Entered: 12/02/2022)
Main Document
Summons Issued
13
Dec 2, 2022
ELECTRONIC SUMMONS ISSUED as to Citadel Securities LLC. (vf) (Entered: 12/02/2022)
Main Document
Summons Issued
Dec 2, 2022
***NOTICE TO ATTORNEY REGARDING DEFICIENT REQUEST FOR ISSUANCE OF SUMMONS. Notice to Attorney Laura Helen Posner to RE-FILE Document No 8. The filing is deficient for the following reason(s): Defendant party name error. Defendant alias party name listed on Summons PDF does not correspond to pleading caption. Re-file the document using the event type Request for Issuance of Summons found under the event list Service of Process - select the correct filer/filers - and attach the correct summons form PDF. (vf) Modified on 12/2/2022 (vf).
Notice to Attorney Regarding Deficient Request for Issuance of Summons
12
Dec 2, 2022
ELECTRONIC SUMMONS ISSUED as to Canaccord Genuity LLC. (vf) (Entered: 12/02/2022)
Main Document
Summons Issued
Dec 2, 2022
Case Designated ECF. (vf)
Case Designated ECF
Dec 2, 2022
Magistrate Judge Gabriel W. Gorenstein is so designated. Pursuant to 28 U.S.C. Section 636(c) and Fed. R. Civ. P. 73(b)(1) parties are notified that they may consent to proceed before a United States Magistrate Judge. Parties who wish to consent may access the necessary form at the following link: https://nysd.uscourts.gov/sites/default/files/2018-06/AO-3.pdf. (vf)
Case Designation
Dec 2, 2022
CASE OPENING INITIAL ASSIGNMENT NOTICE: The above-entitled action is assigned to Judge Gregory H. Woods. Please download and review the Individual Practices of the assigned District Judge, located at https://nysd.uscourts.gov/judges/district-judges. Attorneys are responsible for providing courtesy copies to judges where their Individual Practices require such. Please download and review the ECF Rules and Instructions, located at https://nysd.uscourts.gov/rules/ecf-related-instructions..(vf)
Case Opening Initial Assignment Notice
Dec 2, 2022
***NOTICE TO ATTORNEY REGARDING CIVIL. CASE OPENING STATISTICAL ERROR CORRECTION: Notice to attorney Laura Helen Posner. The following case opening statistical information was erroneously selected/entered: County code New York. The following correction(s) have been made to your case entry: the County code has been modified to XX Out of State. (vf)
Notice to Attorney Regarding Case Opening Statistical Error Correction
Dec 2, 2022
***NOTICE TO ATTORNEY REGARDING PARTY MODIFICATION. Notice to attorney Laura Helen Posner. The party information for the following party/parties has been modified: SUSQUEHANNA INTERNATIONAL GROUP LLP, Northwest Biotherpeutics, Inc. The information for the party/parties has been modified for the following reason/reasons: party name contained a typographical error; party name was entered in all caps. (vf)
Notice to Attorney Regarding Party Modification
11
Dec 1, 2022
NOTICE OF APPEARANCE by Ji Eun Kim on behalf of Northwest Biotherpeutics, Inc..(Kim, Ji Eun) (Entered: 12/01/2022)
Main Document
Notice of Appearance
10
Dec 1, 2022
NOTICE OF APPEARANCE by Michael Benjamin Eisenkraft on behalf of Northwest Biotherpeutics, Inc..(Eisenkraft, Michael) (Entered: 12/01/2022)
Main Document
Notice of Appearance
9
Dec 1, 2022
REQUEST FOR ISSUANCE OF SUMMONS as to Virtu Americas LLC, re: 1 Complaint,. Document filed by Northwest Biotherpeutics, Inc..(Posner, Laura) (Entered: 12/01/2022)
Main Document
Request for Issuance of Summons
8
Dec 1, 2022
REQUEST FOR ISSUANCE OF SUMMONS as to Lime Trading Corp., re: 1 Complaint,. Document filed by Northwest Biotherpeutics, Inc..(Posner, Laura) (Entered: 12/01/2022)
Main Document
Request for Issuance of Summons
7
Dec 1, 2022
REQUEST FOR ISSUANCE OF SUMMONS as to Instinet LLC, re: 1 Complaint,. Document filed by Northwest Biotherpeutics, Inc..(Posner, Laura) (Entered: 12/01/2022)
Main Document
Request for Issuance of Summons
6
Dec 1, 2022
REQUEST FOR ISSUANCE OF SUMMONS as to GTS Securities LLC, re: 1 Complaint,. Document filed by Northwest Biotherpeutics, Inc..(Posner, Laura) (Entered: 12/01/2022)
Main Document
Request for Issuance of Summons
5
Dec 1, 2022
REQUEST FOR ISSUANCE OF SUMMONS as to G1 Execution Services LLC, re: 1 Complaint,. Document filed by Northwest Biotherpeutics, Inc..(Posner, Laura) (Entered: 12/01/2022)
Main Document
Request for Issuance of Summons
4
Dec 1, 2022
REQUEST FOR ISSUANCE OF SUMMONS as to Citadel Securities LLC, re: 1 Complaint,. Document filed by Northwest Biotherpeutics, Inc..(Posner, Laura) (Entered: 12/01/2022)
Main Document
Request for Issuance of Summons
3
Dec 1, 2022
REQUEST FOR ISSUANCE OF SUMMONS as to Canaccord Genuity LLC, re: 1 Complaint,. Document filed by Northwest Biotherpeutics, Inc..(Posner, Laura) (Entered: 12/01/2022)
Main Document
Request for Issuance of Summons
2
Dec 1, 2022
CIVIL COVER SHEET filed..(Posner, Laura) (Entered: 12/01/2022)
Main Document
Civil Cover Sheet
1
Dec 1, 2022
COMPLAINT against Canaccord Genuity LLC, Citadel Securities LLC, G1 Execution Services LLC, GTS Securities LLC, Instinet LLC, Lime Trading Corp., SUSQUEHANNA INTERNATIONAL GROUP LLP, Virtu Americas LLC. (Filing Fee $ 402.00, Receipt Number ANYSDC-27024350)Document filed by Northwest Biotherpeutics, Inc..(Posner, Laura) (Entered: 12/01/2022)
Main Document
Complaint
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Merck CEO says Keytruda is ‘not a repeatable model’
“The future is less monolithic Keytruda,” Davis said. “It’s going to be a lot of smaller, precision-based therapies aimed at specific tumors or indications.”
CHICAGO — Can there be another Keytruda?
Merck CEO Rob Davis, whose company makes the $25 billion-a-year cancer medicine, says it’s a “once-in-a-lifetime drug” whose success won’t be repeated.
“I can tell you at Merck, we’re not out there saying, ‘Let’s find the next Keytruda,’” Davis said at a PhRMA event on the sidelines of this year’s American Society of Clinical Oncology conference. “That was lightning in a bottle. Thank God we found it. The benefit it is having for cancer patients is phenomenal, but it is not a repeatable model.”
The immunotherapy drug will mark the 10-year anniversary of its first approval in September. It’s since been approved for a total of 39 indications across 17 different tumor types. Davis said Merck has spent about $46 billion to date developing the treatment and will spend almost another $20 billion by 2030 as it tests the drug in a wide range of combination studies.
“The future is less monolithic Keytruda,” Davis said. “It’s going to be a lot of smaller, precision-based therapies aimed at specific tumors or indications.”
Davis blamed the Inflation Reduction Act, which drug CEOs have repeatedly said will curtail the development of medicines.
“I worry that with the IRA and the incentives it puts in place, I’m not sure we would have developed Keytruda the same way we did if we were starting today,” he said.
Eli Lilly CEO David Ricks, who also spoke on the panel, likewise said he worried the IRA could lead drugmakers to end development early in the pipeline.
“I don’t know the full story of Keytruda, but from what I understand, it wasn’t known until pretty late in the development what it could be,” Ricks told the audience. “That’s a common pattern. So if we’re terminating ideas before they have time to even grow roots, I think we’re going to miss the next Keytruda.”
Merck is currently working on cancer vaccines with Moderna, precision molecular therapies like in KRAS G12C, and going after specific tumor types with antibody-drug conjugates. Lilly, meanwhile, has launched the weight loss drug Zepbound — which is likely to be a massive blockbuster and has propelled the company’s market value to almost $800 billion.
https://endpts.com/merck-ceo-says-keytruda-is-not-a-repeatable-model/
https://x.com/d_stock07734/status/1795886661412213037
https://x.com/stephmase22/status/1796547602835530157
https://x.com/hoffmann6383/status/1796734688217764244
https://x.com/remouherek/status/1790535725538009404
https://x.com/EcoBiata/status/1796678258815033368
https://x.com/AmgenOncology/status/1786440654312091659
See new posts
Conversation
d_stock
@d_stock07734
An abstract on the use of recombinant interleukin-7 in oncolytic viral therapy for treating GBM. It seems obvious that CYT107 should be included in the future DCVax-L trials.
https://meetings.asco.org/abstracts-presentations/233794
Conclusions: Timing the oncolytic ZIKV injection with the NT-I7-induced peak expansion of peripheral CD8 T cells greatly increased tumor infiltration of cytotoxic T cells and improved survival in the immunotherapy resistant SB28 glioma model. This work suggests a new “expand and pull” approach for the treatment of highly immunosuppressive tumors such as GBM: priming the systemic immune system with NT-I7, followed by an oncolytic stimulus to draw them into the TME to engage and clear tumor cells.
Advancements of Common Gamma-Chain Family Cytokines in Cancer Immunotherapy
https://ncbi.nlm.nih.gov/pmc/articles/PMC8901704/
3:26 PM · May 30, 2024
·
911
Views
Dawson Meirowitz
@dcvaxdaw
@d_stock07734
I suspect abstract at ASCO like the following will become extinct in the next several years.
Single institution analysis of glioblastoma multiforme (GBM) outcomes based on year of diagnosis: A 17 year review.
https://meetings.asco.org/abstracts-presentations/237884
Conclusions:
Despite advances in our knowledge regarding the molecular biology of GBM, prognosis remains poor. Our institution’s 17 year survival data indicates no improvement over time emphasising the urgent need for new treatment strategies. Notably, the more recent time period had an increased number of frailer patients who were too unwell to commence any adjuvant treatment, possibly indicating a lower referral threshold which may have negatively impacted mOS in that cohort. Additionally, the absence of IDH status assessment in the earlier era means some IDH mutant patients were likely included, thereby inflating the mOS for that cohort.
3:07 PM · May 30, 2024
·
862
Views
Tim Thomas
@TimThomas0007
·
May 31
I'm guessing internet articles like Jama and Nature can't make their way all the way out to Cork, Ireland... if not, I'd have to tell Mustafa to put a cork in it...!!!😎
Dawson Meirowitz
@dcvaxdaw
·
May 30
Can’t wait to find out who he will be pitching promoting & trialing in the future like he never heard of dcvax p3 Jama oncology 70 neurooncologists Nov 23
(f) launch of combination treatment trials and trials in cancers other than brain cancer, ?
(g) restart of the DCVax-Direct program,
I suspect the prospective trials will be purely bio-marker driven as shown in the combo trial. CSF1R-I must be included. CYT107 should be included too since it can significantly increase the counts of CD4&8 cells.
https://clinicaltrials.gov/study/NCT00923351sentiment_stocks
Member Level
Re: Nemesis18 post# 695382
Saturday, June 01, 2024 3:40:11 PM
Post#
695429
of 695455
I will start by stating (again) that the vaccine will not cost £250k on its own. I believe that this is the price often stated on the GoFundMe pages, but I think that includes all the ancillary fees (doctor, MRIs, injections, etc.) that go with the vaccine as well, which are not currently covered by the UK health system (since the treatment isn't covered). I'm not sure what the fees would be should DCVax be approved in the UK and be manufactured in the current artisanal fashion that was used in the trial, but I do know that the figure of £150k for how many ever vaccines that could be made had long been planned on fee. That may have changed, since that figure was bandied about more than five years ago.
Of course, the Flaskworks system shaves off 5 days of the human hand work needed and instead applies more of an assembly line automation to the manufacturing process. When this method is finally employed, it will result in a significant savings for everyone... including the UK Govt. In the meantime, they'll likely work out some sort price savings... perhaps where the company makes the entire batch of vaccine, and then charges every time the patient is injected. So instead of paying for the entire batch up front, they'll spread out the cost. And if the patient, or the doctor, believes the vaccine isn't helping, they can stop using it.
I think the goal, here, isn't simply to make oodles of money, but rather, to save lives. And hopefully while doing so, make oodles of money. So far, making the oodles of money hasn't really happened for the majority of investors here. Instead, most of us have poured more and more money into the stock and into the company to help it survive. Obviously, we'd all ultimately like to walk away with much more than we put into it, but only time will tell if that is to be the case.
The only one I can think of who has made money in Northwest, because he brags about it all the time, is iclight.
sentiment_stocks
Member Level
Re: Nemesis18 post# 695382
Saturday, June 01, 2024 3:40:11 PM
Post#
695429
of 695455
I will start by stating (again) that the vaccine will not cost £250k on its own. I believe that this is the price often stated on the GoFundMe pages, but I think that includes all the ancillary fees (doctor, MRIs, injections, etc.) that go with the vaccine as well, which are not currently covered by the UK health system (since the treatment isn't covered). I'm not sure what the fees would be should DCVax be approved in the UK and be manufactured in the current artisanal fashion that was used in the trial, but I do know that the figure of £150k for how many ever vaccines that could be made had long been planned on fee. That may have changed, since that figure was bandied about more than five years ago.
Of course, the Flaskworks system shaves off 5 days of the human hand work needed and instead applies more of an assembly line automation to the manufacturing process. When this method is finally employed, it will result in a significant savings for everyone... including the UK Govt. In the meantime, they'll likely work out some sort price savings... perhaps where the company makes the entire batch of vaccine, and then charges every time the patient is injected. So instead of paying for the entire batch up front, they'll spread out the cost. And if the patient, or the doctor, believes the vaccine isn't helping, they can stop using it.
I think the goal, here, isn't simply to make oodles of money, but rather, to save lives. And hopefully while doing so, make oodles of money. So far, making the oodles of money hasn't really happened for the majority of investors here. Instead, most of us have poured more and more money into the stock and into the company to help it survive. Obviously, we'd all ultimately like to walk away with much more than we put into it, but only time will tell if that is to be the case.
The only one I can think of who has made money in Northwest, because he brags about it all the time, is iclight.
·
#dcvax $nwbo #gbm @MHRAgovuk @NICEComms
— Peter Davis (@peter_brit) May 30, 2024
Good news but a long journey of further development ahead before possibly being available to patients however....
On the 20th December 2023, Northwest Biotherapeutics submited a Marketing Authorization Application the the UK MHRA for… https://t.co/q41CF6VB9H
Nemesis18:Would $ 1 billion in annual Sawston free cash flow by 12/31/29 be of value to NWBO shareholders?
Re: Doc logic post# 695142
Friday, May 31, 2024 10:10:36 AM
Post#
695154
of 695154
I actually believe that dendritic cell combos represent a real opportunity to create effective cancer treatments across the board, but it will be at least 5-10 years before it can even hope to replace SoC, which is both brutal & toxic.
To this end LP has made a very wise business move to create her own manufacturing facility to service Europe in the future.
But I fail to see how Advent’s future success will benefit anyone here as investors ?
It will be Advent that is bought out in the future, NOT NWBO imo.
kabunushi
Re: Nemesis18 post# 695002
Thursday, May 30, 2024 11:54:10 PM
Post#
695071
of 695155
At the risk of being super naive, let me assume that you are on the up and up and of sound mind, and further that everything you say about your description of your experience at KC Oncology Dept. was exactly as you describe it (which is giving your story an enormous amount of credit from a random poster on a MB as you ought to know very well). When you first showed up here, you wrote that you had no beef with NWBO but subsequently, you changed your tune completely. Is there some legit reason for that 180 degree change other than you just getting pissed off because you very understandably didn't get a warm reception here?
Assuming you did have a legitimate beef with a few folks at KC, you've done everything you needed to do to 'protect the NIH' as you put it. What possible justification do you have to come to this investors group and attack NWBO investors as fools every day? Even assuming you have a reasonable beef with NWBO now along with your beef with KC, how do NWBO longs deserve incessant abuse from you just because we don't find your insinuations very credible nor reason to denounce the whole trial?
I mean, what gives you special credibility and default moral high ground here? If you had a legit reason to post here as a PSA, fine. You did that. In my experience, a reasonable person would be done and would piss off, not obsessively haunt the MB, posting every single day. Nobody accepts your story at face value and rightly so. How does that surprise you if you are not stupid?
Unless one really enjoys getting stung, one generally does not take a stick to a hornet's nest and then stick around and repeat the same exercise day after day. This is not the mark of a sensible person. Whatever credibility you might have deserved, frankly, you've walked all over it by being such a complete wanker.
In any case you have never explained how you extrapolated your experience as an individual patient to conclude that everybody at KC including Dr. Ashkan are fake and indeed that the whole DcVax-L trial including the very distinguished Dr. Linda Liau and other deadly serious docs are crooked. That's quite the accusation to make with nothing more to go on than your one very squirrely experience (to the extent we can accept your story at something approaching face value, and if you insist that everybody give you 100% credibility just for showing up here with a story you are suffering from serious delusions of grandeur). Again, if the whole experience at KC went as you describe then you would be justified in being very pissed off but leaping from there to the trial being fraudulent is huge. How do you justify slandering the whole trial involving 70 neurosurgeons, including some of the world's best known names worldwide? Why would you expect anybody to credit what you are claiming with nothing to go on but your one off experience of which we have only heard your side? Forgive me for being blunt; even assuming you are partly legit, you have an incredible sense of your importance. Writing of your experience here once or twice would be reasonable. Writing obsessively here for months is not what I would expect from any 'concerned citizen' of sound mind.
WHEN THE MAA IS APPROVED, THE STOCK MARKET WILL REVEAL WHETHER OR NOT THERE IS A MATERIAL NAKED SHORT POSITION IN $NWBO .
$nwbo has been a manipulated stock for 10 years. Based on the impending MAA approval(https://investorshub.advfn.com/boards/read_msg.aspx?message_id=174511374), the current stock market value of $nwbo should be $ 5 billion , instead of the current $700 million. When MAA approval is announced , bids from large biotechs could set the value at $10 billion.But for now, Ken Griffin and 6 other market makers set the price of $nwbo all day long, every day (
).ken griffin of citadel explains how the big hedge funds control the markets and nothing us little peons do matters pic.twitter.com/fpRtyJpjLN
— Shibetoshi Nakamoto (@BillyM2k) December 11, 2023
ASCO abstracts:
"0 Results for "northeast biotherapeutic"
Did you mean northeast, biotherapeutic, instead of "northeast biotherapeutic"?
WHEN THE MAA IS APPROVED, THE STOCK MARKET WILL REVEAL WHETHER OR NOT THERE IS A MATERIAL NAKED SHORT POSITION IN $NWBO .
$nwbo has been a manipulated stock for 10 years. Based on the impending MAA approval(https://investorshub.advfn.com/boards/read_msg.aspx?message_id=174511374), the current stock market value of $nwbo should be $ 5 billion , instead of the current $700 million. When MAA approval is announced , bids from large biotechs could set the value at $10 billion.But for now, Ken Griffin and 6 other market makers set the price of $nwbo all day long, every day (
).ken griffin of citadel explains how the big hedge funds control the markets and nothing us little peons do matters pic.twitter.com/fpRtyJpjLN
— Shibetoshi Nakamoto (@BillyM2k) December 11, 2023
The biopharma industry is facing a reckoning; Will the market ever fully accept cell therapy? (Fierce Biotech)
This story is the first part in a four-part series about cell therapy, created by the Fierce Biotech team. Gabrielle Masson, Helen Floersh, James Waldron and Max Bayer contributed reporting to this series.
Cell therapy has been slashed by a thousand cuts over the past few years, from the failure of autologous CAR-T to live up to expectations, to market challenges to manufacturing woes. And now, the focus has shifted to autoimmune conditions.
The biopharma industry is now facing a reckoning; Will the market ever fully accept these treatments?
“We've lost our luster in cell therapies,” said Eric Schmidt Ph.D., biotech analyst for Cantor Fitzgerald, in an interview. “It's honestly been a pretty depressing last 12 months or so.”
Sami Corwin, Ph.D., a research analyst at William Blair, calls this moment in time for cell therapy “a pivot.”
Big Pharmas like Sanofi and Bristol Myers Squibb have begun streamlining work in the earlier cell therapy space, confronted with manufacturing challenges and the reality of marketing a personalized therapy. BMS shut down a California research center that was focused on the tumor microenvironment in April as part of a major restructuring.
RELATED
Bristol Myers Squibb closes immuno-oncology, cell therapy-focused Redwood City site
“The changes in our Cell Therapy Organization will streamline and focus efforts on the most promising areas, enabling us to maximize our inline assets, while building the foundation necessary to deliver on our best-in-class pipeline,” a spokesperson for BMS said at the time. The company markets the cell therapy Breyanzi in certain types of lymphoma and leukemia, and Abecma for multiple myeloma.
Days later, BMS signed a $65 million upfront deal with Repertoire to work on tolerizing vaccines for autoimmune diseases, underscoring the pharma's interest in autoimmune.
Also undergoing a pipeline reorganization, Sanofi shuttered legacy business Kiadis, which had been working on developing next-gen, ‘off-the-shelf,’ natural killer cell therapies.
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All of this has led to a muddled present, in which biotechs are walking away from oncology with uncertain partnership opportunities for the near future.
“I guess in part, you can blame capacity and in part you can probably blame the complexity of the therapy. Or maybe you blame the competition as well,” Schmidt said.
RELATED
Sanofi shrinks IGM antibody partnership amid pipeline reprioritization
Even as cell therapies have put out strong data in oncology, the modality has been overshadowed by bispecifics, which have grown quickly in cancer care and surpassed sales for approved cell therapies in the myeloma space, specifically.
“From a commercial standpoint, the autologous products … just haven't really knocked the cover off the ball the way that people might have been hopeful, given how strong the clinical data were,” Schmidt said, speaking specifically to CD19 cell therapies, which include Gilead’s Tecartus, Yescarta and Kymriah and BMS’s Breyanzi.
Gilead has achieved the greatest success with Yescarta, which generated $380 million in net sales for the first quarter. Schmidt calls this the one “shining, positive example” in the field of approved therapies. The remaining approved cell therapies are all at or below $157 million.
But these products have not lived up to the hype elsewhere. “And that’s a real problem,” Schmidt said. “I don't know why. And I’m kind of hard-pressed to think it's just about supply and complexity and delivery.”
Companies have also made slow progress in moving cell therapies into solid tumors, although some progress has been made including the approval of Iovance Biotherapeutics' Amtagvi in melanoma. Mustang Bio and City of Hope also recently showed in an early-stage trial that CAR-T therapy may have a future in the difficult brain cancer glioblastoma.
For Allogene’s Zachary Roberts, M.D., Ph.D., the problems that have dogged cell therapy are simply because the tech wasn’t quite ready when all of these treatments rushed into the clinic.
“I'm fond of saying that autologous products probably would not have been the first cell therapies approved, had we had the advanced gene editing tools that we have today,” said Roberts, EVP of R&D and chief medical officer. “So autologous products, as transformational as they have been, I believe, are essentially a stepping stone to the more cutting-edge allogeneic products like ours, and I'm excited by the in vivo CAR field, although they're still years away, and watching those data develop.”
Cindy Perettie, global head of Gilead’s Kite Pharma unit, said that preclinical data does not translate as well into humans, so there is a huge amount of risk moving things into the clinic.
“Having that phase one bake-off or horse race is really critical in these,” she said.
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Nevertheless, biotechs remain committed to cell therapy. Companies in the space are now going to have to find a way to justify the continued push and bring investors back around.
“We have no idea as an investment community where the bar will be drawn,” Schmidt said. “As you go forward over the next 12 months, there will be a ton of cards to turn over, a ton of learnings.”
Finding the spotlight
The definition of cell therapy is vast and each specific technology has its challenges. Gene-edited cell therapies, for instance, are about to get a huge market test with the recent approval of sickle cell treatments Casgevy (Vertex Pharma and CRISPR Therapeutics) and Lyfgenia (bluebird bio). Both had huge price tags slapped on them and will need to confront the realities of a payer environment that might not be ready for them. That’s another story, however.
Other types of cell therapy include CAR natural killer (NK) cells or T cell receptor (TCR) modified T cells. According to Schmidt, the biotechs working on NK cells have all “pretty much given up,” turning as well to autoimmune and “hoping that the bar is lower.”
“Everyone who's got a platform has repositioned itself to autoimmune disease, more on hope than on any data,” he said.
It’s CAR-T cell therapy that has made the greatest splash in the clinic, only to be sucked back out to sea with reports of relapse among patients.
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One of the first major corrections in CAR-T, which is sometimes referred to as cell-based gene therapy, was when autologous candidates were swapped out for so-called “off the shelf” allogeneic therapies that used donated cells rather than a patient’s own. This was said to ease the manufacturing and patient burden and speed turnaround time.
Many first-gen allogenic biotechs emerged around 2018 with great promise, only to stutter, according to Corwin and Schmidt.
“Outside the autologous products there’s been nothing to cheer about from a clinical standpoint,” Schmidt said. “The allogeneic therapies have, for the most part, taken a step backward.”
Allogene stopped two trials of a CAR-T candidate in advanced lymphoma to focus on minimal residual disease in January. The move will slide cemacabtagene ansegedleucel (cema-cel) to the seventh slot in frontline treatment after six cycles of chemotherapy, where a potential market could exist as doctors tend to simply watch for the 30% of patients who relapse.
Caribou Biosciences, after being dogged by relapses among patients, repositioned itself with a partially matched allogeneic product—not the same as an off-the-shelf option, according to Schmidt. He said the company, which was co-founded by Nobel laureate Jennifer Doudna, Ph.D., is “on thin ice.”
While the bulk of Caribou's pipeline remains focused on cancer, the company was just approved to test CB-010 in autoimmune, too. The trial will cover two types of lupus, lupus nephritis and extra renal lupus.
"We're very encouraged by the initial safety and efficacy data that we've seen with CB-010 in oncology and that really motivated us to choose to also invest in developing it in parallel in lupus," Caribou CEO Rachel Haurwitz told investors at the BofA Securities 2024 Healthcare Conference earlier this month. The chief executive remains confident in the oncology side of CB-010's development program as well, with the company poised to unveil data at the upcoming American Society of Clinical Oncology meeting this week.
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Not ready to give up on its CAR NK technology, Nkarta was cleared by the FDA last fall to test a candidate called NKX019 in lupus, a move that investors cheered. The allogeneic, CD19-directed CAR NK cell therapy was already in clinical testing for B-cell malignancies. Data from the oncology trial revealed in March showed sharply falling response rates, compared to an earlier cohort.
Even CRISPR Tx, which is one of few companies to have a cell therapy approved with the Vertex-partnered Casgevy, pivoted its pipeline in December 2023 toward autoimmune.
Some companies are continuing to try and prove autologous therapies can thrive, bolstered by the regulatory approvals that have come.
BioNTech has been working on its manufacturing process to prepare the CAR-T BNT211 for pivotal trials. The German biotech signed a $250 million upfront deal with Autolus Therapeutics in February to use the company’s manufacturing technology. In return, BioNTech is supporting Autolus’ autologous CD19 CAR-T called obe-cel, which is currently awaiting an FDA decision for B-cell acute lymphoblastic leukemia.
“I am a huge believer in cell therapy. And I think that we are still very much in the first chapter ... And I think what we're doing right now as a field is looking for ways to accelerate and simplify what we have to do with cell therapy to bring approvals in quicker and in interesting ways,” Allogene’s Roberts said.
But now, thanks to some key studies out of Germany, the science on cell therapy has improved and the ability to address larger markets could be within reach. Corwin believes companies that are onto next-gen allogenic may “come back into the spotlight now.”
Editor's Note: This story is part of a series on cell therapy. The second part will be published on May 30. This story was updated on May 29 at 3:23 p.m. ET, to include comments from Caribou CEO Rachel Haurwitz. this story was updated at 9:47 a.m. ET on May 30 to clarify that Allogene's treatment is being tested as the seventh step in frontline chemotherapy.
cell therapy Cell & Gene Therapy Kite Pharma Gilead Sciences Allogene CRO Research Special Reports Biotech
Lykiri
Sunday, May 26, 2024 8:10:22 AM
694029
May 9, 2024
Les Goldman says "they are on track for accelerated approval (150- day assessment)" which is new information.
We know that Northwest Biotherapeutics has requested the MHRA to allow the 150-day assessment route.
December 21, 2023
The MAA seeks approval for commercialization of DCVax-L for both newly diagnosed and recurrent glioblastoma (GBM). The application also requests to be considered under the MHRA’s rapid 150-day review pathway, which the agency has established for new medicines for serious unmet medical needs.
https://nwbio.com/northwest-biotherapeutics-announces-marketing-authorization-applications-submitted-uk-mhra-dcvax-l-glioblastoma/
The MHRA offers only a 150-day assessment timeline for all high-quality marketing authorisation applications (MAAs).
https://www.gov.uk/guidance/guidance-on-150-day-assessment-for-national-applications-for-medicines
I believe that Northwest Biotherapeutics' MAA is well-qualified as a high-quality market authorization application.
October 13, 2023
“The Company strongly believes that after so many years of work on the DCVax-L program, taking some additional time to help ensure that the full MAA package is as strong as it can be is especially important since the Company plans to submit applications to multiple regulators.
https://nwbio.com/northwest-biotherapeutics-provides-update-on-near-term-plans-for-submission-of-marketing-authorization-application/
+ Les Goldman comment regarding accelerated approval in the UK. (Summer 2020)
CHATgpt
The criteria for qualifying for the 150-day assessment route in the UK are designed to ensure that the applications submitted to the MHRA meet specific standards of quality, safety, and efficacy. Here are some key criteria that pharmaceutical companies typically need to fulfill in order to qualify for this expedited review route:
1. **Comprehensive Data:** Applicants must provide a thorough and well-documented set of data on the quality, safety, and efficacy of the drug. This includes results from preclinical studies, clinical trials, manufacturing processes, and stability testing.
2. **Adherence to Good Manufacturing Practices (GMP):** The drug manufacturing facilities must adhere to Good Manufacturing Practices to ensure the quality and consistency of the product. The MHRA may conduct inspections to verify compliance with GMP standards.
3. **Compliance with Regulatory Guidelines:** The MA application should demonstrate compliance with relevant regulatory guidelines and requirements set forth by the MHRA and the European Medicines Agency (EMA), where applicable. This includes submitting all necessary documentation and following standardized procedures.
4. **Innovative or High Medical Need:** Drugs that offer significant therapeutic benefits for patients or address unmet medical needs are often prioritized for the 150-day assessment route. Innovative therapies or those targeting rare diseases may qualify for expedited review.
5. **Early Engagement with the MHRA:** It is advisable for applicants to engage with the MHRA early in the drug development process to discuss regulatory requirements, potential challenges, and any specific considerations for the application. This proactive approach can help streamline the review process.
6. **Risk Management Plan:** The application should include a comprehensive risk management plan to identify, evaluate, and mitigate potential risks associated with the drug, including pharmacovigilance strategies for monitoring safety post-approval.
7. **Benefit-Risk Assessment:** The applicant must provide a detailed benefit-risk assessment that weighs the therapeutic benefits of the drug against potential risks to patient safety. This assessment is crucial for the MHRA to evaluate the overall suitability of the drug for marketing authorization.
By meeting these criteria and submitting a high-quality MA application that aligns with the requirements set by the MHRA, pharmaceutical companies can increase their chances of qualifying for the 150-day assessment route and benefit from the expedited regulatory review process. This pathway aims to facilitate timely access to safe and effective medicines for patients while upholding rigorous regulatory standards.
I believe that Northwest Biotherapeutics' MAA is well-qualified and received confirmation as a high-quality market authorization application. Additionally, on March 7, the Company received confirmation that they were allowed to pursue the 150-day accelerated route. IMO
CHATgpt
The timeline for receiving confirmation that your Marketing Authorization Application (MAA) qualifies for the 150-day assessment route after submission to the Medicines and Healthcare products Regulatory Agency (MHRA) can vary depending on various factors. However, in general, the process typically unfolds as follows:
1. **Validation of MAA:** Upon submission of the MAA to the MHRA, the initial step is the validation process. During validation, the MHRA reviews the application to ensure that it contains all the necessary information and documentation required for assessment. This step typically aims to confirm that the application is complete and meets the basic regulatory requirements.
2. **Notification of Validation:** Once the validation process is complete, the MHRA will notify the applicant that the MAA has been validated. This notification typically confirms that the application has met the initial validation requirements and is proceeding to the next stage of assessment.
3. **Qualification for the 150-Day Assessment Route:** Following validation, the MHRA will then assess the application to determine if it qualifies for the 150-day assessment route. This assessment involves evaluating whether the application meets the specific criteria for expedited review under the 150-day pathway, as discussed in the previous responses.
4. **Confirmation of Qualification:** If the MAA meets the criteria for the 150-day assessment route, the MHRA will inform the applicant that their application has been qualified for expedited review. This notification typically confirms that the application will be subject to the accelerated 150-day timeline for regulatory assessment.
The time between the initial validation of the MAA and confirmation of qualification for the 150-day assessment route can vary, but applicants can generally expect to receive communication from the MHRA within a few weeks to a couple of months, depending on the complexity of the application and the workload of the regulatory authority.
It is important for applicants to engage proactively with the MHRA during the submission process, seek clarification on any requirements or issues that may arise during validation, and maintain open communication to ensure a smooth transition to the expedited review pathway if the application qualifies for the 150-day assessment route.
Overall, while the specific timing of notifications may vary, the MHRA strives to provide timely and transparent communication throughout the regulatory review process to support efficient evaluation of MA applications and expedite access to new medicines for patients in the UK.
hyperopia
Re: Lykiri post# 694029
Sunday, May 26, 2024 8:09:30 PM
Post#
694185
of 694847
Lykiri, thanks for the thoughtful post. I agree that it’s likely that Northwest Bio’s marketing application was high quality, and did not require additional information to be requested from the MHRA, as stated in the 1st quarter report. I also agree that it is highly likely that the application has received priority review.
I personally don’t believe that we can deduce the exact timing of the final decision by the timing of the ASM, or anything that Les said, since the company will only have a general idea of where the MHRA is in the process (and because Les has not exactly been reliable about timing). It appears to me that they have passed the first assessment phase and are now somewhere in the second phase, but it is difficult to know how long this phase will take with the backlog of inspections, and understaffed inspectors at the MHRA. I say this because Les said that no negative disclosures were required in the quarterly report, and he was talking about scheduling site visits, which generally occur after the initial scientific assessment. The company may also be able to deduce where the MHRA is in the process, if their questions change from questions about the application itself, to questions about defining the label, (whether enough evidence was presented for the label to be broad - for all gliomas, or simply for nGBM and rGBM) and post-approval risk management plans, etc.
It seems somewhat irrelevant (to me) to be trying to determine exactly when the assessment started, and counting days in the 150-day assessment timeline when the MHRA hasn’t been close to completing a single assessment in this timeline that was established four years ago. Having said that - I personally don’t know what the second validation date of March 7th means, but I believe that it was determined on or by that date, that the application was complete, and of high quality, so no further information will be officially requested by the MHRA, and the application is entitled and “confirmed” to receive priority review.
I think that, for the purposes of the MHRA’s own timeline, (since they track this) the official assessment (and timeclock) started at the first MHRA validation date of January 24th. I believe that they intend to complete the assessment as soon as they can, but with backlogs, it may take more than 150 days. However, I’ve always hoped the MHRA could pull a rabbit out of its hat for Northwest Bio.
attilathehunt
Re: hyperopia post# 694185
Monday, May 27, 2024 12:57:33 PM
Post#
694261
of 694847
It appears to me that they have passed the first assessment phase and are now somewhere in the second phase, but it is difficult to know how long this phase will take with the backlog of inspections, and understaffed inspectors at the MHRA.
The 10Q came out on the 10th of May and mentioned no dates have been scheduled/established for site visits...LG stated sometime in the fall before 10Q was issued, so it is obvious he was being coy.
With that said, we hear of the ASM on May 22nd (8 business days after 10Q). I therefore speculate, the company received dates on the inspections between those dates and thus the ASM notice.
I'm hopeful we hear of great news by ASM. If not, we are pretty dang close.
hyperopia
Re: attilathehunt post# 694261
Wednesday, May 29, 2024 11:45:42 PM
Post#
694820
of 694847
attilathehunt, I personally think the MAA and ASM timelines are independent, but I can’t deny that it could potentially, “coincidentally” work out that way. If one were counting, 150 days from January 24th is Saturday June 22nd, (and CHM meetings on June 27th and 28th) which would be just before the ASM on Saturday, June 29th.
And speaking of coincidental date alignments; I’m not sure if anyone else noticed that there were CHM meetings held on April 25th and 26th, and there was this, Entry into a Material Definitive Agreement: (which may have been a positive signal of a go ahead)
Loan Entered Into
On April 26, 2024, Northwest Biotherapeutics, Inc. (the “Company”) entered into a Commercial Loan Agreement and Note (collectively, the “Loan Agreement”) with Streeterville Capital, LLC (the “Holder”) in the amount of $11,005,000. The Loan Agreement has a maturity of 22 months. Repayments do not start until December 26, 2024.
The funds will be used for the Company’s ongoing business operations, including beginning initial construction works for the first grade C lab in the Company’s Sawston, UK facility, ordering certain initial long lead-time equipment for the first grade C lab, and facility preparations for delivery of the initial GMP units of the Flaskworks system.
https://www.sec.gov/ix?doc=/Archives/edgar/data/0001072379/000110465924056424/tm2413348d1_8k.htm