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Doc logic; let me know what you think about this post when you have some time.
I believe the narrative that NWBO should form a NewCo (New Company) and/or do a reverse split (r/s) to cause a short squeeze is a narrative, if played to fruition, would only benefit the naked shorts. - post 575287
And then they will have to validate and do comparability. As hyperopia guesstimated when the PR came out, Flaskworks will be ready sometimes toward the end of the year.
Putting the spotlight on these crims can't hurt but they are going to need more than circumstantial evidence to take them down.
But in his letter, Nunes pointed to circumstantial evidence, which included Trump Media stock being in early April the most expensive stock to short in the United States, which he said would give brokers “significant financial incentive to lend non-existent shares.”
The letter links to a CNBC article detailing the sky-high premiums brokers were charging short sellers for loans of Trump Media shares to sell.
Pssst, I know of a good law firm that can help w that. And good luck w the short-selling-prevention tips they recommend.
“For long-term shareholders who believe in the Company’s future, the Company is highlighting the following actions you can take with your brokerage firm to prevent the lending of your shares for short selling,” Trump Media said in its supplement to its FAQ on Wednesday.
The tips include holding DJT shares in a cash account at a brokerage firm as opposed to a margin account, “opting out of any securities lending program,” moving Trump Media shares to the company’s designated transfer agent, and transferring shares to a bank and “holding them in your retirement account.”
The instructions include a helpful form letter that shareholders can send to their brokers.
The letter says, “Please accept this written instruction to make sure that the following securities are held in my cash account only and accordingly are not available for any stock loan activities.”
“I hereby expressly opt-out of any securities lending programs and instruct you to not loan out any of my shares,” the letter says, before a section that the sender can fill out with their number of shares
PS I love this quote from one of the links
A spokeswoman for Trump Media in response to that said, “Citadel Securities, a corporate behemoth that has been fined and censured for an incredibly wide range of offenses including issues related to naked short selling, and is world famous for screwing over everyday retail investors at the behest of other corporations, is the last company on earth that should lecture anyone on ‘integrity.’”
Yes, agree. The article gives a good summation of the last 6 months to go along w the author's (and our) puzzlement on why the share price is so low considering the relatively good news and doesn't consider the # of shares going up by only about 5%, since Sept. 30th as causing that. If, as speculated, there are 2 billion naked short shares, that may have something to do w it and make spoofing look like a stroll in the park.
Being a disciple of "Jack 'quarterly numbers have to be met' Welch" would explain alot. Several years back, there was someone on this board raving about Jack Welch which I thought was BS. Back, in the early 90s, they came out new tech for their refrigerators. Stupid me bought one, The motor lasted about 3 years. What a lemon and they soon discarded that technology. Since then I stopped buying GE products and or buy-in to blowhard Jack.
I can't wait till the 'STFU' thought becomes a reality
Funny thing about this board, once approval and widespread use of dc-vax, I'm sure members will be happy to remind harvard ,and the like ,how wrong they were for years to come. As well as holding those who made disparaging public comments accountable. Hey Dr so and so, remember when you spoke out against dc-vax, guess what, your credibility is gone, explain yourself. Im sure Danish allready has a list going.
there just isn't going to be news until MHRA decision. We're waiting on that for all the other wheels to start rolling. It may well be a huge train, but none of the cars will start moving until the engine (MHRA approval) goes.
Exactly!, and as GoodGuyBill recently reminded us:
Northwest Biotherapeutics Provides Update on Near Term Plans for Submission of Marketing Authorization Application
"The Company and its consultants are working intensively to finalize this last key section of the MAA, after overcoming an unexpected delay in that regard. The Company strongly believes that after so many years of work on the DCVax-L program, taking some additional time to help ensure that [color=red]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
which brings to mind TDD's post
The Danish Dude Re: exwannabe post# 683189 Thursday, April 04, 2024 1:20:06 PM Post# of 683243 Go Trouble with the memory ex? Again?! How convenient.
Asking Chatgbt:
Northwest Biotherapeutics has filed for MHRA approval of DCVax-L. MHRA’s new International Recognition Procedure (IRP) went live from 1 January 2024.
Wheb NWBO receives MHRA approval, can they apply under the IRP for submission to IRP partners as stated here?
"At launch, the MHRA will partner with regulators in Australia, Canada, Japan, Singapore, Switzerland and the USA, as well as the European Medicines Agency, individual EU member states and those in the EEA (European Economic Area)".
And
"In return, our partners can consider applications based on MHRA authorisations, creating a ‘win-win’ for regulators, developers of innovative treatments, and patients".
And would it be possible that NWBO may have submitted through the Access Consortium working-initiative, perhaps not needing to disclose this and if yes, what could the potential benefits of that be?
ChatGPT
Northwest Biotherapeutics seeking MHRA approval for DCVax-L is a significant step for the company, as it may pave the way for broader international recognition and approval through the MHRA's new International Recognition Procedure (IRP) that went live on January 1, 2024. Here's how this process could work for Northwest Biotherapeutics upon receiving MHRA approval:
Application Under IRP to Partner Regulators: Once Northwest Biotherapeutics receives MHRA approval for DCVax-L, they could indeed apply under the IRP for submission to IRP partners. This list includes regulators in Australia, Canada, Japan, Singapore, Switzerland, the USA, the European Medicines Agency, individual EU member states, and those in the EEA. The IRP is designed to streamline the approval process for innovative treatments by allowing international partners to consider applications based on MHRA authorisations.
This could significantly expedite the approval process in these regions, potentially leading to quicker patient access to DCVax-L in these markets.
Submission Through the Access Consortium:
The Access Consortium is a collaboration among several regulatory agencies aimed at expediting the evaluation of pharmaceuticals to ensure timely access to medicines without compromising on safety standards.
If Northwest Biotherapeutics has indeed submitted through the Access Consortium working-initiative, they may not necessarily need to disclose this action publicly. There could be strategic reasons for keeping such submissions confidential, including competitive considerations and the regulatory strategy.
Being part of the Access Consortium could provide several benefits, including:
Streamlined Review Processes: Leveraging the collaborative efforts of member countries to facilitate a more streamlined review process for DCVax-L.
Shared Expertise: Benefiting from the shared expertise and resources of consortium members, potentially leading to more robust and efficient regulatory outcomes.
Expedited Access: Potentially expedited access to markets covered by the consortium members, which could lead to faster patient access to the treatment.
In conclusion, the strategic use of the MHRA's IRP and possibly the Access Consortium could significantly benefit Northwest Biotherapeutics by potentially reducing the time and resources needed to gain approval in multiple jurisdictions. This approach aligns with global regulatory trends aiming to facilitate quicker access to innovative treatments while maintaining high safety and efficacy standards.
IRP or not, MHRAs approval will start the fireworks.
Erroneous argument in comparing Flaskworks to other automated closed cell manufacturing systems. You just need to know that it is priceless in the manufacture of DCVax-L and making it ~12x more efficient than the manual method which is, well, priceless. Those other automated closed cell manufcaturing systems CAN'T make DCVax-L just likes NWBOs semi automated system for Direct, tangential flow filtration, can't make L. An apples to oranges argument.
Hard to know if Flaskworks is worth much of anything with all the other already approved automated closed cell manufcaturing systems already commercially available though.
These thoughts have crossed my mind many many times but I try to push them out just as often; crossing my fingers.
Many here were very critical of the company when they missed on making their initial filing date, than even more criticism when it was further delayed. I believe it's very possible that the reason we're not seeing RFI's now is because of the changes that were made then. I believe that NWBO has been working closely with all four regulators all along and no doubt that has resulted in substantial delay as changes made awaited the acceptance of all four regulators. If one regulator wanted a change, I don't believe they proceeded until all four agreed to whatever the change was. Clearly it takes much longer to get 4 agencies all agreeing to the same thing, but I believe the payoff will come now as approval of DCVax-L will fly through the UK, and through the others as all terms they want in place are ready as well.
They are persistent right now in trying to get shareholders to lend out shares. There must be some event coming up where people/institutions holding short positions could get hurt.
Oh, oh, oh, don't tell me, I think I got this one.
Or men are hunters focusing on one thing only whereas women are gatherers foraging multiple sources be it edible wild plants, insects, eggs, etc which is more attuned to modern corporate structure.
maybe they're seeing what you're seeing, something is askew w the data. Per clinicaltrials.gov.
Canceled submission Indicates that the study sponsor or investigator recalled a submission of study results before quality control (QC) review took place. If the submission was canceled on or after May 8, 2018, the date is shown. After submission of study results, a study record cannot be modified until QC review is completed, unless the submission is canceled.
and
Results returned after quality control review The date on which the National Library of Medicine provided quality control (QC) review comments to the study sponsor or investigator. The sponsor or investigator must address major issues identified in the review comments. If there is a date listed for results returned after quality control review, but there is not a subsequent date listed for results submitted to ClinicalTrials.gov, this means that the submission is pending changes by the sponsor or investigator.
I've been following your discussion w Flipper superficially but if this data/trial is associated w the journal article you posted earlier
Regression of Glioblastoma after Chimeric Antigen Receptor T-Cell Therapy Authors: Christine E. Brown, Ph.D., Darya Alizadeh, Ph.D., Renate Starr, M.S., Lihong Weng, M.D., Jamie R. Wagner, B.A., Araceli Naranjo, B.A., Julie R. Ostberg, Ph.D., +14, and Behnam Badie, M.D.Author Info & Affiliations Published December 29, 2016 N Engl J Med 2016;375:2561-2569 DOI: 10.1056/NEJMoa1610497 VOL. 375 NO. 2
I think there will be some revisions based on if, after a QC/QA re-review, the data initially provided needs to be corrected.
Kudos to Hoffmann's summary. On another note, in reading this summary, I can't help but think how Streeterville Capital/Fife would benefit from the loan agreements they negotiated w NWBO w at a lower price.
Yes, I found it interesting/fascinating in multiple ways. Thanks for sharing.
I found it fascinating that Bo, after getting his tumor resected and not having enough tumor to make enough doses, waited for his tumor to grow back bigger so that after a 2nd resection, he would have enough tumor to make enough DCVax-L. This guy will have inadvertently, or not, created a new SoC (for DCVax-L), whereas you don't immediately resect the tumor, you wait till it grows big enough so that you'll be able to manufacture enough doses. The balls on this guy to wait w the possibility of the bigger tumor impacting some critical function or perhaps the tumor becoming non-resectable. But w chemo being the other option, he had no other option in my book, or in the books of those aware of DCVax-L's potential.
I found it interesting that an American did not have a problem in going to Kings College for DCVax to be processed. I kind of thought that wouldn't be a problem but you never know how much red tape you need to get thru.
And thirdly, I found it interesting that they treated him for Grade 3 Oligodendroglioma and not grade 4 GBM. As you know the MAA is for nd and rGBM but the PIM designation for DCVax-L covers ALL malignant gliomas. Interesting.
Yes, UCLA clearly has stated publicly in PR documentation that the trial is DCVax-L but I wanted to test drive Exs claim. On the face of it, he seemed to be making a valid observation but giving it a little thought, it's a clunker of a claim that I can see for myself w/o the need for UCLAs support. Basically, I did this exercise for my own head and other longs who might have thought similarly.
No, not saying a new leuko is done for each dose. In the UCLA process the partially mature DCs are frozen then thawed as needed a day before the dose to be activated via the lysate. That becomes a batch.
So let me get this straight:
The current UCLA process is the partially mature DCs are frozen then thawed as needed a day before the dose to be activated via the lysate. Vs The clinical process is the partially mature DCs are activated and frozen till needed.
They already did a comparability study for the Sawston facility (1 of the 5 workstreams). A Comparability study for Flaskworks should be a piece of cake. Here’s a little segment about what the EMEA says about it:
The demonstration of comparability does not necessarily mean that the quality attributes of the pre-change and post-change product are identical, but that they are highly similar and that the existing knowledge is sufficiently predictive to ensure that any differences in quality attributes have no adverse impact upon safety or efficacy of the drug product. A determination of comparability can be based on a combination of analytical testing, biological assays, and, in some cases, nonclinical and clinical data. If a manufacturer can provide assurance of comparability through analytical studies alone, nonclinical or clinical studies with the post-change product are not warranted. However, where the relationship between specific quality attributes and safety and efficacy has not been established, and differences between quality attributes of the pre- and post-change product are observed, it might be appropriate to include a combination of quality, nonclinical, and/or clinical studies in the comparability exercise. To identify the impact of a manufacturing process change, a careful evaluation of all foreseeable consequences for the product should be performed. In consideration of this evaluation, appropriate criteria to define highly similar post-change product can be established. Generally, quality data on the pre- and post-change product are generated, and a comparison is performed that integrates and evaluates all data collected, e.g., routine batch analyses, in-process control, process validation/evaluation data, characterisation and stability, if appropriate. The comparison of the results to the predefined criteria should allow an objective assessment of whether or not the pre- and post-change product are comparable. Following the evaluation of the quality attributes, the manufacturer could be faced with one of several outcomes, including: Based on appropriate comparison of relevant quality attributes, pre- and postchange product are highly similar and considered comparable, i.e., no adverse impact on safety or efficacy profiles is foreseen; • Although the pre- and post change product appear highly similar, the analytical procedures used are not sufficient to discern relevant differences that can impact the safety and efficacy of the product. The manufacturer should consider employing additional testing (e.g., further characterisation) or nonclinical and/or clinical studies to reach a definitive conclusion; • Although the pre- and post-change product appear highly similar, some differences have been observed in the quality attributes of the pre-change and post-change product, but it can be justified that no adverse impact on safety or efficacy profiles is expected, based on the manufacturer’s accumulated experience, relevant information, and data. In these circumstances, pre- and postchange product can be considered comparable; • Although the pre- and post-change product appear highly similar, some differences have been identified in the comparison of quality attributes and a possible adverse impact on safety and efficacy profiles cannot be excluded. In such situations, the generation and analysis of additional data on quality attributes are unlikely to assist in determining whether pre- and post-change product are comparable. The manufacturer should consider performing nonclinical and/or clinical studies; • Differences in the quality attributes are so significant that it is determined that the products are not highly similar and are therefore not comparable. This outcome is not within the scope of this document and is not discussed further.
And this is what it says in a pending patent application for “Methods Related To Activated Dendritic Cells Compositions”, which shows that via testing they can characterize the final DCVax product.
The proposed method, including determining the relative amounts of IL-6, IL-8, IL-12 and TNFa and comparing them with threshold values, can be used to increase the immunotherapeutic activity of a population of activated dendritic cells and to determine the effectiveness of immunotherapy in a patient
I agree basically w what you say which would be optimum but I don’t see BP giving top dollar just from drug approval. BP would have a hard time convincing their shareholders, who are not familiar w this paradigm shifting drug, of a justifiable partnership/buyout price. IMHO, NWBO would need to show BP and their shareholders/BOD that if they don’t pony up they’ll continue to go it alone till BP offers a buyout price or partnership in NWBOs ballpark. The United Kingdom is the training ground to show what DCVax-L is all about. The United Kingdom is that display window which will entice prospective buyers to step on in and check under the hood. That’s my view outside looking in which is akin to looking at the outside of a watch and trying to figure out how it works. Good luck w that and w what NWBO is thinking🙃. All IMHO.
Yep, Medarex was worth a lot more. It had a great pipeline but had a very weak CEO in Howard Pien and some other weak management types such as Chris Schade and Laura Choi. The company was based in NJ but Pien managed the company from California. Selling the company was perfect for his retirement but not for us investors.
NWBOs 25 employees gives me hope that they will go it alone for GBM in the United Kingdom. When I checked Linked In several weeks ago, I counted 16 employees but my Linked In search skills aren't that great and/or some employees didn't show up there. I was looking for signs they hired key personnel that would enable them to go it alone such as VPs/Directors of Medical, Quality, Regulatory Affairs, Manufacturing (they still need a presence here even if Advent is kind of doing the job), and perhaps Clinical, etc but didn't see them. Bottom line is when I saw the NWBO personnel on Linked In, NWBO didn't appear to be gearing up to go it alone but if some of those 9 additional employees are some of those key employees I noted then going alone may not be out of the Q. My belief is that NWBO needs to show they are serious about going alone to get the best deals possible w BP. Once BP sees that NWBO is serious about going it alone, it will be easier to get deals done for GBM or other indications in the United Kingdom and other regulatory jurisdictions. LP has already gone on record that for GBM they will go it alone for GBM.
antihama Re: None Monday, November 21, 2022 5:44:45 PM Post# of 536986 Go Regarding partnerships, LP has already gone on record that for GBM they will go it alone. Here’s what LP said in 2010 at the Oppenheimer 25th Annual Health Conference Conference attendee #5: But then, how are you thinking about the regulatory process element? You touched on that, but how are you thinking about commercializing it? Are you going to... because it may be a huge effort given, you know, how many patients you have... Umm
Linda Powers: Are you asking if we're going to do it ourselves or if we're going to partner it? That's always the elephant in the room, so I'll just say it for you. Umm, certainly for sure in brain cancer we're going to do it ourselves. In the whole United States the American Association of Neurosurgeons, AANS, it only has about 3000 surgeon members. And of those, a few hundred are brain surgeons for brain cancer, right. You have a target audience of a few hundred. You have a sales force of 20 people, each of them covering 25 doctors. Bingo, you're there. Right? And that's the U.S. market, that's pretty big. We've given a lot of thought to this. Also, today, if you think about it, what would a big-Pharma bring to the table with this type of a product? Right? They don't have any manufacturing capabilities for a cellular product. They don't have any distribution infrastructure for a cellular product, especially a frozen one, which goes in frozen dry-shippers. Which by the way, there are all kinds of practicalities to this. We ship the product in what are called, 'dry shippers.' Which if remember the little robot in Star Wars, R2D2. It kind of looks like a tall R2D2, right. It's powered by liquid nitrogen. The temperature is stable for at least 12 to 14 days. So if you ship it, and somebody loses it on a loading dock for 3 or 4 days, no problem, you're fine, right. So there's a lot of practicality. Pharma hasn't developed any of that. Right, umm, so really the only thing that Pharma could bring to the table would be, their checkbook. And, umm, we'd rather not be bought. And now w the JAMA article, the knocking on 200 brain surgeons doors is gonna be much easier than it ever was. Regarding partnerships for other indications, I am also in the ‘partnership is the way to go’ camp, and the sooner the better because that will give shareholders assurance that it’s not just shareholders seeing DCVax as a gem.
If you or others have the answer at your fingertips, I'm curious to know how many employees they had from the last couple of 10Ks, otherwise it's something I'll check when I have some time beginning w how to find that info in the current 10K.
There are so many jokes to be had from your political view both negative and positive but the bottom line is I don't think any politician wants to be associated or hint of any connection w you.
my thoughts have been archived here now, and some may wish to reflect on them at the end of March.
Just pretentious Bullchit`. Not on ignore yet (but soon) because I find this concern of yours for us shareholders somewhat humorous. You just can't make this stuff up.
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