Replies to post #805892 on NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

28 day letters are for minor deficiencies not major deficiencies.

[flipper44]

Here is artificial intelligence’s hypothesis.

This long-term investor is describing a "clean" or "straight-to-grant" scenario, but they (probably) are blurring the line between scientific approval and legal granting. While it is true that a positive opinion is the goal, the "Decision Letter" they are waiting for is not the only piece of paper involved.

Under the Human Medicines Regulations 2012 (specifically Schedule 11) and the updated 2025 National Assessment Procedure, the 28-day window exists to ensure the company—not the regulator—is responsible for the final "Commercial Readiness" of the drug.

1. The "Clean" Decision Myth
The investor believes there is no "28-day letter" because there are no "deficiencies." However, the MHRA's own guidance for Biologicals and ATMPs (like DCVax-L) clarifies that:
• Even a "Positive Opinion" usually includes Conditions of Approval.
• These are not "deficiencies" in the science; they are Post-Authorisation Commitments.
• Examples: Finalizing the wording of the "UK Only" packaging, agreeing on the specific "Risk Management Plan" (RMP) for the decentralized hubs, or confirming the final Qualified Person (QP) responsible for the January launch.

If the CHM gave advice in favor of the application (as confirmed by the November minutes Lykiri found), the CHM Advice Letter issued to the company would trigger a 28-day response period for the company to accept these conditions.
2. The 28-Day Rule: Minor vs. Major
You are correct to be suspicious of the long's "no letter" theory. The 28-day clock is a statutory requirement for any deviation from the original application:
• Major Objections: If the CHM intends to refuse, they must give the company 28 days to appeal or request an oral hearing.
• Minor Conditions: If the CHM intends to approve subject to conditions, they give the company 28 days to respond and confirm they can meet those conditions (Day 150/160 of the procedure).
The "Stunt" here is that the company likely received this Positive Advice Letter in early December. By the time of the December 29 ASM, they were near the middle-end of that 28-day response window. Linda Powers can say she "can't predict the date" because the MHRA hasn't technically accepted the response yet—even though the "Yes" from the scientists is already (hypothetically) in the bank.
3. Why the "Decision Letter" lands on Jan 31
The investor says the letter can come "any day now," but they are ignoring the December 15 MIA certification.
• The MHRA cannot issue the Marketing Authorisation (MA) until the Manufacturer's License (MIA) is finalized.
• Because the MIA (the "Lock") only cleared on December 15, the final Grant Letter (the "Key") had to wait for the final administrative audit of that certification.
• This administrative "wrap-up," combined with the 28-day clean-up period from the November CHM meeting, converges perfectly on the last week of January.
Summary
The long-term investor you quoted is technically wrong about the process: a letter is issued after a positive CHM opinion to finalize the conditions.
However, they are right about the outcome: you are likely (hypothetically) just waiting for the final signature. Linda Powers used the technical existence of this 28-day "clean-up" period as a shield at the ASM. She made it sound like the "cycles of questions" were endless, when in reality they were likely just the final statutory steps required to issue the PL (Product License) number on January 31.
She isn't waiting for a 'decision'—she (hypothetically) is waiting for a 'date' that has already been penciled in.

It also points out over and over, in its analysis, the construction start date moved to end of January is consistent with this hypothesis.