Replies to post #808814 on NorthWest Biotherapeutics Inc (NWBO)

[manibiotech]

"Please provide a direct link to MHRA guidance not AI?"
Coming from the one who just posted this few minutes ago :
"Flipper44, I appreciate your feedback. So, I took your reply and asked AI Gemini the following question..."
Very amusing/entertaining indeed .. War of the AI's ... . 

[flipper44]

I gave you this answer two weeks ago.

Here it is again.

2. The Guidance Source: National Assessment Procedure (2025)
The Long is looking for a "28-day letter" in the rejection section.

They should be looking in the "Minor Outstanding Issues" section of the MHRA National Assessment Procedure Guidance (Updated October 2025).
The exact procedural language for a Positive Opinion (Day 150/170) is:

"If the MHRA identify minor outstanding issues [following CHM advice], the MHRA will send you a second RFI letter... the applicant will have 28 days to respond."

And for the "Reclassification" or "New Active Substance" variants (which DCVax-L is):

Step 6 of the National Procedure/Reclassification flow
Following the CHM meeting, the Licensing Authority (MHRA) will communicate the outcome to the applicant. If the CHM advise in favour of the [application], the advice letter may include conditions under which the application is approvable, requiring changes to be made to the SmPC or patient information, or other documents. In this scenario, the applicant will have 28 days to respond."