is...Long
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Dr Monica Bertangelli 4 Natl Inst Health gets 15-6 House Committee vote.
— maverick_1 (@maveric92283613) October 25, 2023
Senate for confirmation of NIH 18 mos w/o a Director.
Would give NWBO Fast Track for Cancer Moonshot$NWBO for GENERATIONAL WEALTH in extending/Saving Lives
-us-nih-nominee-gets-helping-hand?v=preview
My point is that we know dendritic cell vaccines work, real value is in efficiently manufacturing DCVax. A closed loop manufacturing process allows for markets to see DCVax as a personalized 'off the shelf' product. Stop asking about RA approval and ask when is flaskworks ready.
— Future (@Doc_Hieu) October 22, 2023
I wonder which field of medicine will receive the next round of national and international medical and scientific awards. 🚀 $NWBO https://t.co/BVDBlHE4nv
— Bio99 (@BIO99_BIO99) October 24, 2023
It’s coming. $NWBO https://t.co/HZ767LGyRS
— Bio99 (@BIO99_BIO99) October 24, 2023
Some would argue that Mass General (one of Harvard's hospitals) is the most important research hospital in the world. Well it just announced that an immunotherapy leader at Harvard will be its next Chief Academic Officer. “We believe that in the next 5 to 10 years, many new…
— Bio99 (@BIO99_BIO99) October 25, 2023
Promising Pathway Act 2 minute overview https://t.co/sgg9oHDFxg@SenateAgingGOP #PPA
— Al Musella (@AlMusella) October 23, 2023
Stay up to date on the latest practice-changing advancements in #Glioblastoma management with experts @StevenBremMD & @BrainTumorDoc! Join PeerView on Thursday, November 16th at 5:15 PM PST during #SNO2023! https://t.co/8PTUiXsCC1 #BTSM #BrainTumor #MedEd pic.twitter.com/Arb41ItRRI
— PeerView (@PeerView) October 21, 2023
Shattering the Barriers to Glioblastoma Care
Revolutionary Advances With Innovative Technologies and Modern Systemic Approaches
Live In-Person and Virtual Symposium on Thursday, November 16, 2023
Steven Brem presenting. It should be noted that This activity is supported by an educational grant from Novocure, Inc.so unsure how much will be said about DCVax.
Shattering the Barriers to Glioblastoma Care: Revolutionary Advances With Innovative Technologies and Modern Systemic Approaches
Activity Description
In recent years, further evidence in the underlying pathophysiology of glioblastoma has led to the emergence of various diagnostic and therapeutic options. Several innovative modalities, including Tumor Treating Fields (TTFields) and efficacious systemic therapies have been introduced and incorporated into clinical practice guidelines, and numerous clinical trials utilizing a variety of ground breaking therapeutic strategies are shattering previous barriers that prevented oncology professionals from providing personalized care.
In this Peer View Seminars & Practicum educational symposium, experts will utilize real-world patient case scenarios to provide guidance for the effective management of glioblastoma including a comprehensive understanding of the most recent evidence supporting established and emerging diagnostic and therapeutic options to equip learners with the necessary skills to develop team-based, individualized treatment plans for patients with glioblastoma. Break through the barriers and provide your patients with the highest standards of glioblastoma care today!
Target Audience
This activity has been designed to meet the educational needs of neuro-oncologists, medical oncologists, radiation oncologists, neurosurgeons, advanced practice clinicians, and other healthcare professionals involved in the care of patients with glioblastoma.
Educational Objectives
Upon completion of this activity, participants should be better able to:
Cite current clinical evidence supporting modern and emerging therapies for patients with newly diagnosed or recurrent glioblastoma, including TTFields and systemic therapy options
Apply strategies for selecting between modern therapies for glioblastoma based on the latest evidence, expert recommendations, and individual patient needs
Develop team-based strategies to address practical aspects of care involving established and novel therapies for patients with glioblastoma, including strategies to manage and mitigate adverse events
Faculty
Chair/Planner
Steven Brem, MD
Hospital of the University of Pennsylvania
Penn Brain Tumor Center
Abramson Cancer Center
Philadelphia, Pennsylvania
https://lrn.peerview.com/150208821_1/150208821_1_p1/stage1reg?Promocode=980&AudienceID=SNO&ProfessionID=4&MemberID=316922636&EmailID=303542828&CountryID=GB&ProjectNumber=150208821_1
https://lrn.peerview.com/150208821_1/150208821_1_p1/stage1reg?Promocode=980&AudienceID=SNO&CountryID=GB&ProjectNumber=150208821_1&MemberID=316922636&EmailID=303542828&ProfessionID=4
"Now, some people may try to argue that the evidence is circumstantial. But, as we all know, circumstantial evidence is often the most convincing kind of evidence. For example, let's say you find your spouse in bed with another person. That is circumstantial evidence, but it's pretty convincing evidence that they're cheating on you" 🤣🤣
#dcvax #allsolidtumors $nwbo #gbm
— Peter Davis (@peter_brit) October 21, 2023
I asked ChatGBT to summarize the key points and potential for the following:-
1."Association of Autologous Tumor Lysate-Loaded Dendritic Cell Vaccination With Extension of Survival Among Patients With Newly Diagnosed and Recurrent… pic.twitter.com/THOuNIB1g4
Lone⭐️ 343434
@maxstradamus21
$NWBO. Look at the size of this partnership.
Daiichi Sankyo and Merck Announce Global Development and Commercialization Collaboration for Three Daiichi Sankyo DXd ADCs
"Collaboration combines Daiichi Sankyo’s proven ADC expertise and DXd technology with Merck’s deep experience in oncology and clinical development capabilities to advance and expand the reach of ADCs for patients across multiple types of cancer
Daiichi Sankyo and Merck to co-develop and co-commercialize patritumab deruxtecan, ifinatamab deruxtecan and raludotatug deruxtecan worldwide except for Japan where Daiichi Sankyo retains exclusive rights
Merck to pay Daiichi Sankyo a $4 billion upfront payment in addition to $1.5 billion in continuation payments over the next 24 months, and may make additional payments of up to $16.5 billion contingent upon the achievement of future sales milestones, for a total potential consideration of up to $22 billion"
https://www.merck.com/news/daiichi-sankyo-and-merck-announce-global-development-and-commercialization-collaboration-for-three-daiichi-sankyo-dxd-adcs/
#dcvax #allsolidtumors $nwbo #gbm
— Peter Davis (@peter_brit) October 20, 2023
ChatGPT summary of key findings and their significance in the phase 2 combination results currently pending peer-review in the NATURE journal:-https://t.co/A1C5bAjGG0 pic.twitter.com/d95oPhUJE6
#dcvax #allsolidtumors $nwbo #gbm
— Peter Davis (@peter_brit) October 20, 2023
Thanks @HenryMuney , summary of patent provided by ChatGPT:- pic.twitter.com/uJx9bwYjVA
Interesting that some NVCR insiders started to sell positions (beginning of Sept) only taken a few months prior (End of June) immediately after NVCR reported the failure of it's phase 3 for recurrent ovarian cancer. Speaks volumes....
#dcvax #allsolidtumors $nwbo #gbm
— Peter Davis (@peter_brit) October 20, 2023
I find this an interesting insight into the minds of $nvcr Insiders. The recent four sales by insiders were relatively small in relation to the number of shares they held but were quickly sold at a loss within two months+. Any confidence… pic.twitter.com/AZK1UXOeKM
Likely delaying tactics, he would like to delay implementation indefinitely. Let's face it, he has a lot to hide and less transparency is his 'friend'
#dcvax #allsolidtumors $nwbo #gbm https://t.co/eBpBfD9KMm pic.twitter.com/ihpwvvDsTf
— Peter Davis (@peter_brit) October 17, 2023
Just the trial design approval is being quickened for the lowest-risk phase three and four trials which will be processed by MHRA within 14 days – rather than the statutory 30. Anything that quickens the process is a positive but not a massive improvement, and again just for trial designs not approval of the drug.
“Our new notification scheme is exactly that. It will reduce the time taken to get the lowest-risk clinical trials up and running without undermining patient safety.”
The NHS and its patients are set to benefit from a new initiative that will see clinical trial approval reduce by more than 50%.
The scheme comes from the Medicines and Healthcare products Regulatory Agency (MHRA) and means that applications for the lowest-risk phase three and four trials will be processed by MHRA within 14 days – rather than the statutory 30.
https://www.nationalhealthexecutive.com/articles/low-risk-late-stage-clinical-trials-will-be-approved-within-two-weeks-mhra-says
"Another lost year with false promises by management"
So let us look at the evidence:-
"The Company anticipates submitting the MAA in approximately the next 30-45 days"
No promise by the company just a 'forward looking statement' What do the company regularly advise it's shareholders about such statements ?
"In addition to historical information, this report contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Such forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from those projected. The words “believe,” “expect,” “intend,” “anticipate,” and similar expressions are used to identify forward-looking statements, but some forward-looking statements are expressed differently. Many factors could affect our actual results, including those factors described under “Risk Factors” in our Form 10-K for the year ended December 31, 2022 and in Part II Item 1A of this report. These factors, among others, could cause results to differ materially from those presently anticipated by us. You should not place undue reliance on these forward-looking statements"
https://nwbio.com/northwest-biotherapeutics-announces-completion-of-prerequisites-and-plans-for-submission-of-marketing-authorization-application/
https://www.sec.gov/ix.xhtml?doc=/Archives/edgar/data/1072379/000141057823001633/nwbo-20230630x10q.htm#Item1ARiskFactors_812647
So many privileged people being photographed with Dr. Liau lately. Her scientific achievements make her an A lister. https://t.co/5eVnFOMlgW pic.twitter.com/uLky8QULf0
— Justin Keister MS DABR (@justinkeister5) October 15, 2023
Absolutely laughable Gensler talking about possible future risks to the market with all the illegal activities he currently takes no action/inadequate action on. Of course there is going to be a financial crisis and possibly before the events he is discussing. That's the result of being complicit to widespread fraud.
Gary Gensler urges regulators to tame AI risks to financial stability
SEC head warns reliance on a few data models could unleash a financial crisis within a decade
Gensler declined to comment on whether scope 3 disclosures, which were welcomed by investors but slammed by corporate America, would be included in the rule’s final version.
Regulators must quickly find a way to manage risks posed to financial stability by the concentration of power in artificial intelligence platforms, the chair of the US Securities and Exchange Commission has urged.
Gary Gensler told the Financial Times that without swift intervention it was “nearly unavoidable” that AI would trigger a financial crisis within a decade.
Shaping AI regulation would be a tough test for US regulators, the SEC chair said, as potential risks cut across financial markets and stem from models crafted by tech companies that sit outside the remit of Wall Street watchdogs.
“It’s frankly a hard challenge,” Gensler said. “It’s a hard financial stability issue to address because most of our regulation is about individual institutions, individual banks, individual money market funds, individual brokers; it’s just in the nature of what we do. And this is about a horizontal [matter whereby] many institutions might be relying on the same underlying base model or underlying data aggregator.”
The SEC in July proposed a rule addressing potential conflicts of interest in predictive data analytics, but it focused on individual models deployed by broker dealers and investment advisers.
Even if current measures were updated, “it still doesn’t get to this horizontal issue?.?.?.?if everybody’s relying on a base model and the base model is sitting not at the broker dealer, but it’s sitting at one of the big tech companies”, Gensler said. “And how many cloud providers [which tend to offer AI as a service] do we have in this country?”
He added: “I’ve raised this at the Financial Stability Board. I’ve raised it at the Financial Stability Oversight Council. I think it’s really a cross-regulatory challenge”.
Regulators worldwide are grappling with how to police AI, as tech groups and their models are not naturally captured by specific watchdogs. The EU has moved quickly, drafting tough measures over the use of AI in a groundbreaking law that is set to be fully approved by the end of the year. The US, however, is reviewing the technology to determine which aspects of it require new regulation and what is subject to existing laws.
Wall Street has already adopted AI in a number of ways, from robo advising to account opening processes and in brokerage apps.
But Gensler is concerned that parties basing decisions on the same data model may lead to herd behaviour that would undermine financial stability and unleash the next crisis.
“I do think we will in the future have a financial crisis?.?.?.[and] in the after action reports people will say ‘Aha! There was either one data aggregator or one model?.?.?.?we’ve relied on’. Maybe it’s in the mortgage market. Maybe it’s in some sector of the equity market,” Gensler said.
AI’s powerful “economics of networks” makes it “nearly unavoidable,” he added, predicting that a crisis could happen as soon as the late 2020s or early 2030s.
Lawmakers and regulators in Washington have heightened scrutiny of AI, raising concerns around market stability, data protection and antitrust. The Federal Trade Commission in July launched a review of ChatGPT maker OpenAI looking at consumer harm and data security. Antitrust agencies have warned that AI’s structural dependence on scale could lead to tech monopolies.
Gensler, who has tackled concentration in capital markets to promote efficiency, believes that AI could generate competition issues in that area. “Might this lead to more concentration of market makers?” he said.
The SEC is also finalising a much expected rule, proposed in March 2022, that requires public companies to disclose their direct emissions and emissions derived from energy that they purchase, known respectively as scope 1 and scope 2. Under the proposal, scope 3 emissions, a broad measurement that includes products a business buys from third parties, would need to be reported only if they were deemed “material” or part of companies’ climate targets.
Gensler declined to comment on whether scope 3 disclosures, which were welcomed by investors but slammed by corporate America, would be included in the rule’s final version.
However, he said he would do “the right thing by the American public by doing a rule that’s within the law and is sustained by the courts [and] thinking that through based on the comments [the SEC has received], based on the economics, based on trying to bring some consistency to what’s already happening”.
He noted that in 2021, 55 per cent of companies in the Russell 1000 already disclosed scope one and scope two emissions.
The climate proposal has angered Republican lawmakers and attorneys-general, two dozen of whom have threatened to sue the SEC on the basis it is overstepping its authority, a claim Gensler denies. The chair’s active rulemaking agenda is facing other legal challenges, including a lawsuit from a coalition of private equity, venture capital and hedge fund groups seeking to block sweeping new measures for private fund managers.
https://www.ft.com/content/8227636f-e819-443a-aeba-c8237f0ec1ac
"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 the full MAA package is as strong as it can be is especially important since the Company plans to submit applications to multiple regulators"
I fully endorse this stance from the company and this is exactly why:-
Waiting for NWBO to slip up...
Let us put things into perspective, so we have learned that they had to ammend their plans due to unexpected circumstances. They advised this within the 45 day previously announced timeline. The company even advise investors that these things are possible in every financial statement under 'forward looking statements. SUCH IS LIFE
Nothing significant has changed, in 2024 we will have approvals in 4 countries, it is possible that we may have one or more partnership agreements and multiple combo trials started , it is also possible that we are approved for rGBM as well as nGBM and maybe other types of brain cancer as well.
This is what I am focused on, not a small delay, show me another company with the same pps and the same potential just over the next 12 months. We all have the same options BUY, HOLD or SELL, I know what I am doing.
#dcvax #allsolidtumors $nwbo #gbm https://t.co/tzNZzjEyBi
— Peter Davis (@peter_brit) October 14, 2023
Digging deeper into today's $NWBO update and considering the context of their last 10Q, the following questions arise.
— Bio99 (@BIO99_BIO99) October 13, 2023
If you were the $NWBO CEO, would you risk fast-tracking a potentially flawed MHRA submission when you could submit a perfect submission to multiple regulators…
For further clarity, provided by the company today
'The company plans to provide updates when the delivery is made to the publisher and when the MAA is submitted'
Good so no need for endless speculation we have seen to date.
NWBO UPDATE Expected to be submitted between mid and late November
The Company reported that the majority of the MAA has been completed, and all but one of the key sections of the MAA have been delivered to the publisher. The publisher is an independent party who does the final step of the preparation for the submission: formatting, checking references and the like.
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 the full MAA package is as strong as it can be is especially important since the Company plans to submit applications to multiple regulators.
An additional factor in the timeline is that certain expert consultants who are key to this remaining section will be temporarily unavailable during the next two-week period, returning the week of October 30. The Company anticipates that the remaining section of the MAA package will be delivered to the publisher within about two weeks after the consultants return.
The Company further anticipates that once this last section of the MAA is delivered to the publisher, they will need about two to three weeks to complete their work on both the last portion and the integrated whole. With this timeline, the submission of the MAA to the MHRA would take place between mid and late November. The Company plans to provide updates when the delivery is made to the publisher and when the MAA is submitted.
https://www.prnewswire.com/news-releases/northwest-biotherapeutics-provides-update-on-near-term-plans-for-submission-of-marketing-authorization-application-301956184.html
One thing for certain, I am pretty sure the company are regretting putting out the guidance at all. I find it easier to take a good look at the 'larger picture' which helps avoid short-term disappointments. My expectations are quite simple in that I firmly believe we will receive UK MHRA approval no later than March next year. I am totally confident this will happen and whatever needs to take place in order for this to be achieved will happen. For me personally, approval no later than March is fine and I fully expect approvals by all of the four regulators by the end of 2024. Of course I could be wrong with my expectations and will be happy if any of these are met sooner but will be happy either way.
#dcvax #allsolidtumors $nwbo #gbm https://t.co/tz3m53LFM9
— Peter Davis (@peter_brit) October 13, 2023
Totally agree Doc. and let's not forget the company did state "they had a plan for shorts" and that "perhaps they are walking into a trap" so that being said, I would expect the unexpected.
#EuroBio23: The downturn, taking risks and the ‘biotech mafia’
Big Pharma: Some have more to lose than others as they face the looming loss of exclusivity for major franchises. What’s going to fill the multibillion-dollar gap? There aren’t enough late-stage programs to go around; they’ll have to place bets in the preclinical and early clinical space. For biotechs, that means “going back to the old playbook” for incremental capital and taking the licensing deals instead of keeping crown jewels all to themselves, said Ron Gerber, senior managing director at Guggenheim Securities.
https://endpts.com/eurobio23-the-downturn-taking-risks-and-the-biotech-mafia/
#dcvax #allsolidtumors $nwbo #gbm
— Peter Davis (@peter_brit) October 12, 2023
Excellent work by @FlemmingBruce https://t.co/M77QOTXmBv… https://t.co/vRtcyOOrkU… And try to ask BARD the question below. pic.twitter.com/ZRRcjikvwM
Of course there are those with agenda who like to bring up any 'promising' potentially competitive trials including rat studies etc in order to further this agenda in spreading fear, uncertainty and doubt however, not much due diligence is required to determine just how far behind such companies as Diakonos Immunotherapies really are for example (see below), with their 'Dendritic cell vaccine' the target date for completion of the PHASE 1 is not until 2024! With 2025 target of completion of their Sarcoma clinical phase 1 trial. Also, the rest of their pipeline is even further behind. Their 'Intratumoral injection start date for IND-Enabling (prior to phase 1) is not targeted for starting until 2024 and similarly their CAR T Cell Protocol IND-Enabling trial is also not targeted for start date until 2024.
.
"Fast track designation has substantially de-risked this drug and this company"
The fact is that despite the endorsement of Fast track designation there are huge, expensive and time-consuming hurdles for this (and any other company at a similar stage of very early development} DCVax® is a good example in that it has been in development for over twenty years and overcome many, many obstacles to get to this point of imminent approvals.
Just look at this one statement taken from the list below, any drug in development has to at the very least replicate any positive efficacy and safety results through to their phase 2 trial, until this happens it is just one of so many phase 1 trials showing positive results that may or may not go onto further success and perhaps chance of approval. Bearing in mind this possibility:-
• On average, it takes 10.5 years for a Phase I asset to progress to regulatory
"Phase II development remains the largest hurdle in drug development, with just 28.9% of candidates achieving this critical phase transition"
Key Takeaways
• The overall likelihood of approval (LOA) from Phase I for all developmental candidates over 2011–2020 was
7.9%.
• Phase II development remains the largest hurdle in drug development, with just 28.9% of candidates
achieving this critical phase transition.
• Of the 14 major disease areas, Hematology therapies had the highest LOA from Phase I (23.9%), representing
a seven-fold increase over the least successful group, Urology (3.6%).
• Immuno-oncology therapies provide a rare pocket of success in oncology R&D with an overall LOA of 12.4%
vs 5.3% for all oncology approaches.
• Rare disease therapies were notably successful with an overall LOA of 17.0%.
• Chronic, high prevalence disease therapies were less successful with an overall LOA of 5.9%.
• Biological complexity in drug modalities generally leads to higher LOA, with CAR-T and RNA interference
achieving the highest LOAs of 17.3% and 13.5%, respectively.
• Development programs with trials employing patient preselection biomarkers have two-fold higher LOAs
(15.9%), driven by a Phase II success rate of nearly one-in-two.
• The top contributing factors toward phase success are disease indication, target, modality, and drug
novelty.
• On average, it takes 10.5 years for a Phase I asset to progress to regulatory
https://www.cphi-online.com/clinical-development-success-rates-and-news111181.html
Well, it's another false narrative put out by them that a BP would never pay more than 100% premium over current value debunked. At least they are consistent, that is consistently wrong 🤣
None of their drugs in development are even past phase 1
https://www.diakonosoncology.com/
$NWBO
— hoffmann6383 (@hoffmann6383) October 10, 2023
Another data point to consider regarding the potential scale of the MM's alleged naked short covering scheme.
Remember when Defendant broker-dealers complained that allowing NWBO's lawsuit to continue would flood the courts with further litigation as this type of… pic.twitter.com/3krqS6I3nx
I think too much attention is given to the 'Tuesday' being more probable day for PR's. For sure historically it has the most PR's but if you go back the last two years of PR's it is far from conclusive:-
28th October 2021 - Thursday
29th November 2021 - Monday
21st December 2021 - Tuesday
17th February 2022 - Thursday
4th May 2022 - Wednesday
10th May 2022 - Thursday
05th June 2022 - Sunday
06th July 2022 - Wednesday
23rd August 2022 - Tuesday
17th November 2022 - Thursday
06th January 2023 - Friday
20th March 2023 - Monday
29th August 2023 - Tuesday
12th September 2023 - Tuesday
Only 4 Tuesdays out of the last 14 PR's