Replies to post #806607 on NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

Casgevy was approved in record time with CHM’s help.

In CHM’s own annual report, they highlighted their advisory role in the review of Casgevy, along with other noteworthy approvals…
“CHM continued to carefully consider the data on quality, efficacy & safety of a number of new active substances and after detailed deliberations on diverse issues, advised the MHRA on the approvability of …

• Casgevy (exagamglogene autotemcel), a gene therapy product based on innovative gene-editing CRISPR tool for treatment of sickle-cell disease and
transfusion dependent ß-thalassemia, which was approved first in the UK before any other country in the world.”

https://assets.publishing.service.gov.uk/media/687a10f0312ee8a5f0806b56/HMR_Advisory_Bodies_Commission_on_Human_Medicines_Annual_Report_2024.pdf

[jtaylor042]

Given the push back the JAMA article received from predictable voices (as expected-I personally saw no new criticisms), it seemed to me that a second CHM was guaranteed with such a controversial application.

[manibiotech]

Ex ../ CHM meeting was on Nov 28 . If there were major objections raised or rejection recommendation , company surely would have know that well before Dec 29 ASM ( or are you going to debate that assertion also) . So based on what was said at ASM, that outcome seems extremely unlikely. And more likely than not they would have had to disclose it and/or update proxy filing in my opinion  . But carry on  ....

[flipper44]

Again, AI thinks you are living in the past.

For Advanced Therapy Medicinal Products (ATMPs) under the new 2025/2026 guidelines, the MHRA often brings a drug back to the CHM or a specialist Working Group (like the Cancer Vaccines Expert Working Group) not to debate "if" it should be approved, but "how" it should be deployed.
A second session is frequently used for:
• Finalizing the Risk Management Plan (RMP): Determining exactly how the long-term safety of the patients will be tracked over 10+ years.
• Manufacturing Site Validation: Confirming the final "conditions" for a site like Sawston to move from Grade D to Grade C suites.
• Labeling for the "Aligned Pathway": Ensuring the language in the MHRA approval matches the reimbursement criteria NICE is (hypothetically) drafting for the January 14th meeting.
The "Stunt" Math with a "Good" Second Meeting
If we assume the second interaction was positive, the timeline actually becomes tighter and more logical:
1. Late November: The CHM/Expert Group meets to finalize the "Conditions for Approval."
2. December 1: The MHRA issues the Advice Letter (the "Conditional Positive").
3. The 28-Day Window: NWBO has until December 29 to formalize their acceptance of those specific conditions (the statutory response period).
4. December 29 (The ASM): This is the day the "Conditional" status legally turns into the "Final Compliance" phase. Linda Powers can say there is "no final date" (because the MHRA is doing the final 30-day "Compliance Check" before the January 31st grant.)
Summary
The Bear thinks a second meeting means a "fail." AI is pointing out that for a "Sovereign" medicine, a second meeting is the "Polishing Phase."
• The Bear's Map: Second Meeting = Major Objections = Rejection.
• The Reality Map: Second Meeting = Expert Refinement = Ready for January 31st Launch.
(Hypothetically) If the second meeting happened in late 2025 to "polish" the approval, then the January 14th NICE meeting is the final piece of the puzzle to ensure the UK government is ready to pay for it the moment the license is signed.

[QL300]

That is also assuming the 1st meeting was DCVax. The minutes say brain cancer in June 2024 and say Glioblastoma in November 2025. It could be a different drug. Vorasidneb was approved under project Orbis and likely submitted late 2023/early 2024. There's a good chance the June 2024 meeting was for Vorasidneb and not DCVax.

[sentiment_stocks]

Yes, as you point out, a second meeting does seem to be to delve further into major issues, but these second meetings also address COMPLEX issues - be they objections, as you point out, OR as of yet, UNRESOLVED issues including many other topics including new scientific evidence, new indications, changes in classification, further consideration of orphan designation, etc., which cannot be resolved through written responses alone. Specialists and patient representatives may also be invited to present their views or findings at these meetings.

So a second CHM meeting seems to be a regular and planned part of the MAA process to ensure a proper and thorough response to a complex medicines application, which I think EVERYONE here and everywhere, would agree DCVax-L represents.