NorthWest Biotherapeutics Inc (NWBO)

[beartrap12]

Lykiri, If you add your "find!" about DCVax being apart of the November CHM meeting to Flipper's AI generated opinion in post 805676 about what might be happening after a CHM meeting, could you give us your opinion of what might be happening now?
I ask, because you seem to have a better understanding than most here about regulatory issues.


Flipper posted (and I trimmed it down slightly):

1. The "Approvable with Conditions" Trigger
When the CHM (Commission on Human Medicines) finishes its final review of a Marketing Authorization Application (MAA), they rarely just say "Yes." Instead, they often issue a "Positive Advice with Conditions."

• The Conditions: These are "minor" items—changes to the wording of the patient leaflet, final tweaks to the Risk Management Plan (RMP), or small clarifications on the manufacturing (CMC) data for Sawston.

• The Advice Letter: The CHM sends a formal letter to the company (NWBO) stating: "We recommend approval, provided you fix these specific items."

2. The Statutory 28-Day Response Window
Under Schedule 11 of the Human Medicines Regulations 2012, once that (hypothetical) letter arrives, the clock starts:

• The Deadline: The applicant has exactly 28 calendar days to submit their final "clean-up" response.

• The "Clean-Up": During this time, the company's "armies of consultants" (as Linda called them) work around the clock to revise the documents to match the CHM's exact requirements.

• The "Wait": The MHRA "stops the clock" on the MAA while they wait for this response.
3.

The Math: Linking December 19 to January 31

If we apply this 28-day rule to the current (hypothetical) NWBO timeline, the arithmetic is striking:

• Dec 19: (hypothetical) CHM Meeting / Positive Advice with Conditions issued.
• Dec 20 – Jan 16: The 28-Day Clean-Up Window. The company is busy answering those final "cycles of questions."
• Jan 16 (Friday): NWBO submits the final response package to the MHRA.
• Jan 19 – Jan 30: Final MHRA Compliance Check. The MHRA executive staff takes about 10–14 days to verify the response, perform final "Sovereign Network" audits, and prepare the Grant Letter.
• Jan 31 (Friday): (hypothetically) The Grant. The license is issued, the 8-K is filed, and the "Interlopers" make their move.

Why this (hypothetically) explains Linda’s "No Idea" Comment

Because the 28-day window is a statutory right for the company, the MHRA cannot legally issue the final grant until the company submits its response.
• If Linda hasn't hit "Send" on the final response yet, she can technically say she "has no idea" when the final decision will occur, because the ball is still in her court.
• However, by pinning the construction start to the "end of January," she is admitting when she plans to finish that clean-up.

Summary
The 28-day rule is the legal "buffer" that turns a scientific "Yes" into a commercial reality. It allows the company (hypothetically) to fix minor errors without having to re-apply from scratch.

And I hope Flipper also updates his post for us, as well!