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That wasn’t just for the IRP.
Number 1. Was for IRP
Here is number 2. Again,
Accelerated approval process.
From 2024, the MHRA WILL also implement a “swift approval process” for the most impactful new medicines and technologies, such as “cancer vaccines and AI therapeutics for mental health.”
In respect of medicines, we note that the MHRA currently offers a 150-day assessment route for high-quality national MA applications and the option for applications to be fast tracked if there is compelling evidence of benefit in a public health emergency or if there is a shortage of supply of an essential medicine. We will need to wait for further detail before we know whether the MHRA will be able to accelerate these timelines even further and what the specific product criteria will be for this accelerated assessment route.
The Government announced £10 million extra funding for the MHRA over the next two years to implement the above ambitions.
It’s a potential program announced by Jeremy Hunt in March of 2023, partially funded by a 10 minion dollar infusion for matters like SWIFT and IRP.
Accelerated approval process.
From 2024, the MHRA will also implement a “swift approval process” for the most impactful new medicines and technologies, such as “cancer vaccines and AI therapeutics for mental health.”
I think the silence on (probable) validation confirmation just helps big fish who want to buy huge dips. I don’t think silence on the matter protects retail, PPS, nor does silence reduce dilution. Vertex/CRSPR were kind enough to announce submission, validation and approval.
Bard AI:
The MHRA typically sends a copy of the validation report confirming validation to the sponsor when they initially validate an MAA. This report is crucial for the sponsor to understand the status of their application and any necessary actions to proceed.
Here's a breakdown of what happens during validation and the information included in the report:
Validation Process:
Review: The MHRA thoroughly examines the MAA to ensure it meets all regulatory requirements, including:
Completeness
Formatting
Compliance with guidelines
Presence of necessary data and supporting documents
Identifying Issues: If any deficiencies or omissions are found, the MHRA will raise them in the validation report.
Communication: The MHRA sends the validation report to the sponsor, usually within 30 days of receiving the application.
Validation Report Contents:
Validation status: Clearly states whether the MAA has been validated or not.
List of deficiencies (if any): Details any missing information or areas that need correction.
Instructions for addressing issues: Provides guidance on how to rectify any deficiencies.
Timelines for resubmission: Specifies deadlines for resubmitting the corrected application.
Contact information for further inquiries: Provides contact details for any questions or clarifications.
Key Points:
Validation is essential: It's not an assessment of the medicine's quality, safety, or efficacy; it's a check for completeness and compliance with regulatory requirements.
Sponsor's responsibility: The sponsor must address any deficiencies highlighted in the validation report and resubmit the application accordingly.
Communication is key: The MHRA and sponsor should maintain open communication throughout the process to ensure timely validation and progression of the MAA.
Additional Information:
MHRA guidance: The MHRA publishes detailed guidance on the validation process and requirements for MAAs.
Contact the MHRA: For specific inquiries or concerns, it's always best to contact the MHRA directly.
December 30, 2022. Linda Powers:
But now that the Phase III trial is done and as soon as we've got the application for approval cemented, we're very eager to proceed with these combos. I will say we -- again about the past, we will be looking for the terms to be favorable for Northwest and its shareholders.
— Linda Powers
If you cement an agreement or relationship, you make it unlikely to change. — Cambridge Dictionary
3D printed fish filet? Great, could they also print some tartar sauce?
IRP in the spotlight during 2023. “UK first” may increasingly overshadow in 2024.
Well of course the UK and drug companies mutually benefit from IRP’s efficiencies, but what regulator should companies submit their marketing application to first?
SWIFT, if and when implemented, may make that decision easier for companies with high impact technologies, like cancer vaccines.
Make no mistake about it, even though IRP is an efficient tool, when you hear U.K. regulators get truly excited, it’s lately likely due to someone mentioning CRSPR, and before that, the Covid-19 vaccine approval.
High impact therapeutics is becoming their specialty. Companies are beginning to see this. Not only that, other regulators followed the U.K. regarding those two products.
The UK now has speed of high impact approvals, first Covid vaccine, and complex high impact approval, CRSPR, as impressive trophies on their post-Brexit shelf.
Combining these two characteristics, accelerated and complex approvals is the Holy Grail. SWIFT could leapfrog other regulators’ velocity, while (possibly) applying it to an autologous vaccine for cancer could demonstrate capability to shepherd complex scaled up manufacturing and ECA data to a comprehensive approval.
For a historically respected agency, this would be an excellent way to attract more high impact therapy companies to submit in the “UK First.”
”Though that is wrong, though the lack of clarity on IP is comical.” — exwannabe
Thanks.
I read your posts on this from about November 22, 2023 forward. My own recollection was that LP stated one or two years ago some BP were starting to improve their cell manufacturing. That would be in line with your views.
Your posts since late November on manufacturing are industrious, and, one must only guess that BP is trying to keep a lid on things (camouflage their true goal), as they often do, (in order to believe your hypothesis).
I have no idea, but keep up the good work!
I’m starting to think NWBO might be a pilot participant for the proposed SWIFT program which might be able to review in 60 days (SWIFT is not formal yet, but is supposed to be ready in 2024)
I’ve given some other reasons why this is possible, including but not limited to LP’s new program proclivities, strange behavior by some better publicly informed longs, MHRA’s tendency to pilot before full implementation, the express reference to cancer vaccine applicability, etc. The list is quite long.
I think it’s possible nwbo was assigned a “special” veteran team (which is a tool SWIFT wants to incorporate), perhaps some previously worked on the CRSPR process.
I think it’s possible MHRA had an Oncology Expert Working Group advising NWBO prior to submission.
I really didn't and don't think MHRA wants DCVax-l to hit bumps once NWBO submitted their maa. Therefore setbacks, if any, were to occur before submission.
I think SWIFT, motivated by cancer vaccine type technology (“high impact”), oncology working groups and veteran special teams assigned upon submission will get this done at lightening speed.
MHRA still has some of the best and most qualified regulator professionals on the planet. Their restructuring post Brexit wasn’t going to slow the UK down for long. Now, imo, patients will soon reap the benefits.
I believe Daltrey is mostly wrong about that. Instead, if cancer is “cured,” this will allow researchers, resources and medical providers to shift and focus on remaining diseases like Alzheimers.
Good job at not understanding when they were investigating as some time leading up to and including 2017 to 2022.
Yes, facts are an excellent way to shut down a conversation.
More facts
During the Relevant Period, (2017 - 2022) Defendants engaged in spoofing to manipulate the price of NWBO shares on OTC Link LLC and NYSE ARCA Global OTC, thus creating an imbalance in the market for NWBO shares and inducing other market participants to buy or sell at artificial prices. In order to carry out their spoofing scheme, Defendants placed tens of millions of Baiting Orders and executed millions of orders at manipulated prices during the Relevant Period. Indeed, Defendants engaged in spoofing on 395 of 1,171—or nearly 34%—of the trading days during the Relevant Period. — Cohen/Milstein/Posner
You’re peculiarly off on everything, including May 10.
Here, try this.
https://www.cohenmilstein.com/case-study/northwest-biotherapeutics-inc-securities-litigation/
TCTrader and I discussed the possibility that NWBO was being spoofed back in 2016.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=125190845&txt2find=Spoof
Apparently the investigation started shortly thereafter.
It’s up to the court system to judge how it was methodically used against NWBO, to what degree and the damages.
One thing is obvious, the more data points, the easier to prove, and May 10 was probably a very big data point.
It would not have taken a boot on NWBO’s throat to mess with their market value, merely a thumb on the scale by Market Makers, thus also constantly impacting market sentiment towards the company.
As a consequence, NWBO would need to pursue less favorable financings and dilute at low PPS.
As a consequence, market sentiment would deteriorate further.
Spoofing a vulnerable but promising biotech is akin to the butterfly effect. There are many downstream negative ramifications.
As a consequence, resources were rationed, other trials placed on hold, automation efforts economically dwindled.
If methodical spoofing is found. The world may have to live without the Citadels and other MMs that made it occur. They think of themselves as irreplaceable in market mechanics.
They are mistaken.
The trial was first submitted to clinical trials.gov on September 17, 2002.
After several design modifications, the trial ran from August 2007 to November 2015, 331 patients with nGBM were enrolled.
The Company undertook a limited period of enrollment in 2008, and then kept the trial going with the patients already enrolled, but suspended new enrollment due to resource constraints during the worst of the economic downturn, through the end of 2010. The Company began the process of reactivating clinical trial sites for new enrollment in Q1 2011, and resumed screening in Q2 of 2011.
The company reached data lock in October of 2020. The trial was about 13 years old at that point.
The trial is continuing to collect important long term “follow up” survival data. The trial is currently over 16 years old, with patient data spanning over eight to sixteen years.
I have to attend to some other things today, so maybe someone else can help you out with your other questions.
It’s dufus not duffus, dufus.🥸
I’ve read this article before, and I’m still a bit perplexed on how they are using the word franchise under these circumstances. Could somebody add more color, and save the jokes please, unless you also incorporate a serious answer as well.
Bard’s detailed timeline of Merck’s acquisition of Prometheus.
2022:
May 25, 2022: Initial discussions and due diligence begin.
July 2022: News leaks, propelling Prometheus' stock price up.
At this point, Prometheus' lead candidate, PRA023, is in Phase 2b clinical trials for ulcerative colitis and Crohn's disease.
August 2022: Both companies remain silent, but speculation around the potential acquisition is rife.
2023:
February 23, 2023: Merck officially announces the $10.8 billion acquisition, representing a 75% premium. PRA023 remains in Phase 2b.
March-June 2023: Regulatory reviews and shareholder meetings take place.
June 29, 2023: Acquisition finalized, making Prometheus a wholly-owned subsidiary of Merck.
July-December 2023: Integration process commences, encompassing Prometheus employees, assets, and pipeline projects.
December 2023: Merck announces promising early-stage results for MK-7240 (formerly PRA023), paving the way for Phase 3 trials in 2024.
2024 (so far):
January 13, 2024: Integration and development of the Prometheus pipeline continues within Merck.
Additional notes:
Merck was attracted to Prometheus' strong pipeline, particularly PRA023's potential to become a "best-in-class" treatment for inflammatory bowel disease.
The acquisition price reflected
1. the perceived value of PRA023, and
2. the future potential of Prometheus i. technology and ii. expertise.
The successful integration of Prometheus and the advancement of its pipeline, including PRA023, will be crucial to the acquisition's long-term success.
I hope this revised timeline with the additional information adds clarity and context to the Merck-Prometheus deal.
You were right. Posner’s response showed up an hour and minutes after filing.
Apparently, while only needing to file an amended complaint in the near future, Posner did not find anything objectionable in the Judge’s ruling? It’s past midnight.
This is very much in line with the possibility of SWIFT. I’d start considering SWIFT slightly more likely than when I last addressed (previously very long shot) Not only due to Hoffman’s post, but also the apparent fence placed on this.
I must say the idea of SWIFT likely assigning special teams to high impact therapies (like cancer vaccines) in order to manage an expeditious approval process is refreshing.
It has nothing to do about money being brought in, it would instead have to do with publicly signaling they’ll be ok with fully diluted shares being over the limit in 60 days from their announcement. Of course, I have no clue when they would do this.
I know nobody takes Breezewoods “1/24” date seriously, but I thought it was a fun riddle.
Here’s my guess.
CHM meeting is targeted for March 21/22.
Normally their recommendations within a couple days?
Both March 21 and March 22 minus 60 calendar days is Monday January 22, but tack back on a couple days for decision making.
So what would the 60 days entail?
Beats me, but what if it was management 60 day noticing their intent to exercise options? Just a wild ass guess to a meaningless riddle.
People gave you negative reactions for that, but I tend to agree both will file later (closer to midnight), because both objections are due at the same time. Usually, it seems motions alternate who has something due, but not today. So I’d imagine Posner will be a little closer to the wire today/tonight, because neither party wants to give the other party time to modify their response once they’ve seen the other response. JMHO
How could they buy on the open market if they held knowledge regarding some accelerated pathway — for instance?
What could happen, is LP and Les 60 day notice intent to exercise their blocked options, but that’s just speculation.
Come on man….
Hoffman was predicting January 3 for acceptance. All of a sudden, once we entered 2024, he’s correcting himself calling it validation and very low chance to be announced.
Something happened.
Senti and BrightBoy said, hold my beer, and claimed validation occurred immediately upon submission. (While it is true, apparently, validation reverts to submission date, validation has not been known to take less than a few days after submission.). But Senti said, end of discussion.
Many people fell in line.
Now smith is repeating same general concept of Validation is simultaneous.
Anyway, Smith goes on to do the same range as Hyperopia. Could be really soon, but odds are July. Smith says 150+ days the likely route but who knows. He definitely, in his mind believes the approval pathway type will not be discussed before approval decision made. He literally made this point three times.
Before removing her linked in, Canadian Power hoped for 150 day, but appropriately cautioned off clock time might be added. Then she said something interesting. She was interested in seeing what new accelerated guidance might be coming out. Think this might have been before Christmas, before the echo chamber.
Another post pointed out SWIFT might be a new pathway. I think Abeta first found general MHRA reference about Swift.
Swift, it turns out, aims to prioritze high impact treatments like cancer vaccines (I kid you not) and AI mental health therapy. Swift can reach approval within as little as 60 days when implemented.
I asked Bard if MHRA might use pilot test cases before fully implementing a new program. It emphatically agreed, and one example it gave was when MHRA ran test cases before fully adopting a pathway to increase device approval speed.
Who knows what pathway is invoked, but it might be fast, no wait, accelerated, umm, or swift.
What we do know is the circulating echo chamber is, don’t announce validation, also won’t announce which pathway, could be really soon but most likely July and Smith Doc and DD almost seem to be licking their chops at retail being decimated by their predicted six month silence treatment — with no intervening affirmations like validation.
I guess underpar71 is disagreeing that he entered the bet.
OK. Thanks.
I’m not trying to be a pain, but weren’t you one of the folks that lost the submission bet in December 2023?
Got this from Bard, so take it with a grain of salt. Food for thought.
Yes, the MHRA frequently employs pilot test cases before fully implementing new programs. This practice is a crucial part of their strategy to ensure the effectiveness, safety, and smooth rollout of new initiatives. Here's a breakdown of why they use pilot testing and how they conduct it:
Purposes of Pilot Testing:
Identifying Issues Early: Pilot testing allows the MHRA to uncover potential problems, risks, or shortcomings within a new program before it's broadly implemented. This helps them make necessary adjustments or refinements to optimize the program's success.
Evaluating Feasibility and Effectiveness: Pilot projects enable the MHRA to assess whether a program is practical and likely to achieve its intended outcomes in real-world settings. This includes evaluating its impact on stakeholders, resource requirements, and potential challenges.
Gathering User Feedback: Pilot testing provides an opportunity to collect valuable feedback from users, stakeholders, and staff involved in the trial. This feedback can inform improvements to the program's design, implementation, or communication strategies.
Refining Processes and Procedures: The MHRA can use pilot testing to test and refine the processes, procedures, and tools associated with a new program, ensuring their clarity, efficiency, and alignment with regulatory requirements.
Examples of MHRA Pilot Projects:
Combined Ways of Working Pilot: This pilot aimed to streamline the ethical and regulatory review of clinical trials by allowing simultaneous submission to both the MHRA and Research Ethics Committees.
In Vitro Diagnostic Medical Devices
Assessment Pilot (IDAP): This pilot tested a new regulatory pathway for innovative in vitro diagnostic medical devices, aiming to accelerate their access to patients.
Patient Involvement in Clinical Research Pilot: This pilot explored ways to enhance patient participation in clinical research and drug development, aiming to improve the relevance and outcomes of research studies.
Key Considerations in Pilot Testing:
Clear Objectives: The MHRA carefully defines the goals and success criteria for each pilot project to ensure focused evaluation and meaningful results.
Appropriate Scope and Duration: Pilot projects are tailored to the specific program being tested, with a suitable scope and duration to gather sufficient evidence for decision-making.
Data Collection and Analysis: The MHRA collects comprehensive data during pilot projects, covering various aspects such as impact on stakeholders, resource utilization, and overall effectiveness. This data is then rigorously analyzed to inform decision-making.
Transparency and Communication: The MHRA often shares information about pilot projects with stakeholders and the public, ensuring transparency and fostering collaboration.
By consistently utilizing pilot testing, the MHRA takes a proactive approach to ensuring the quality, safety, and effectiveness of new programs, ultimately contributing to better regulatory outcomes and public health protection.
Well, we won’t get a chance to chat much if MHRA pilots NWBO into SWIFT, which is a very long shot at this point, but if they do/did, You should probably start packing up your Ihub virtual desk. No chit chats for you if approval in 2024.
Who knows? Here’s an article saying SWIFT actually from 2024.
https://www.biopharma-reporter.com/Article/2023/03/16/mhra-gets-10m-boost-from-uk-government
LP likes being part of new programs.
Not saying that’s the case here, but most of these types of programs start with pilot test cases before becoming official.
I just literally gave a post about MHRA programs that exist and one that’s going into effect. The post said nothing about NWBO, and you are literally challenging me to leave if the MHRA doesn’t implement programs that are already implemented.
They say there is no such thing as a a stupid question, but damned if you didn’t prove them wrong icilight.
Ok ex, time’s up.
The MHRA offers various avenues for expedited approval of well-prepared marketing authorization applications MAAs. Therefore, it's crucial to understand both existing initiatives and new proposals like SWIFT — Streamlined Workflow for Innovative Trials.
Existing Initiatives
1. The Prime Pathway fast-tracks promising new medicines addressing life-threatening conditions with decisions within 150 days.
2. The 150-Day Assessment tries to assess all high-quality MAAs within 150 days, incentivizing thorough preparation. This was initiated at the beginning of 2024.
3. MHRA Scientific Advice Service gives early feedback on MAAs before formal submission helps address potential issues.
4. Quality and Compliance Guidance provides detailed resources assist applicants in preparing high-quality MAAs.
5. MHRA Submissions platform enables secure and efficient electronic submission, reducing administrative delays.
6. Risk-based approach tailors review intensity based on drug complexity and risk profile for efficient assessment.
Factors for faster approvals
Well-organized data with clear presentation reduces review time.
Compelling evidence strengthens the case for faster approval.
Proactive communication with the MHRA facilitates a smoother review.
Strict adherence minimizes delays due to non-compliance.
Very very soon, the SWIFT program will further streamline the review process for innovative medicines, particularly gene and cell therapies.
Proposes a single assessment pathway with a dedicated team familiar with these complex products.
Targets 60-day assessment timelines for certain innovative MAAs.
Currently undergoing stakeholder consultation and expected to be implemented in 2024.
SWIFT will provide potentially faster access to breakthrough therapies for patients with unmet needs.
Reduced uncertainty and development costs for companies developing innovative medicines.
Streamlined regulatory environment for the UK to remain competitive in attracting global clinical trials.
MHRA Corporate Plan 2023-2026 https://www.gov.uk/government/publications/mhra-corporate-plan-2023-to-2026
Prime Pathway
https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency
MHRA Scientific Advice Service https://www.gov.uk/guidance/medicines-get-scientific-advice-from-mhra
MHRA SWIFT Proposal
https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency
Ok. I will. I guess I’ll answer the question for myself. I was trying to help you be the one to lay your case out regarding what I was asking for, but I’ll tell you what I find tomorrow.
You tell me. I’m not a Merck expert, but to my knowledge Merck does not commercially market any (anti-cancer) cellular therapies.
They have said this in 2022 about clinical efforts.
Cell-Based Therapies & T/NK Cell Engagers: Through our collaborations with Dragonfly and Janux Therapeutics, we are exploring bi- and tri-specific Natural Killer and T-cell engagers. We are also evaluating allogeneic cell therapies through our collaborations with Artiva and A2 Biotherapeutics.
To freeze cellular tissue.