NorthWest Biotherapeutics Inc (NWBO)

[sentiment_stocks]

Always pay attention to Lykiri's posts. ALWAYS. But here, I'll help.

the new National Assessment Procedure, which introduces formal timelines such as the 28-day representations period and the CHM letter mechanism, applies only to applications submitted on or after April 3, 2025. The DCVax-L MAA review began on April 1, 2024, so it falls under the previous procedure, in which there was no formal requirement for a CHM letter or a 28-day representations period. Therefore, even under the previous framework, a positive CHM opinion would not result in a CHM letter, IMO.

Regarding next steps after a positive CHM opinion, I would expect the MHRA to proceed with the standard process for granting the marketing authorisation under the applicable (pre-April 2025) procedure.
Post #805827

Additionally, LP (as a lawyer), had she been in possession of a 28 day letter citing a CHM recommendation to deny the MA would never have said at the 12/29/25 ASM statements such as she made:

we are really, really gratified by how much work and how much resources the agency is devoting to our case. They’re doing an enormous amount of work on our case, inspections and analyses and so forth. And our advisors have commented on this too, and have expressed to us that they are impressed with the amount of resources being devoted. So that’s a positive, and we’re gratified by it.

The second thing is, I can say that we are continuing to be actively engaged. We are going through cycles of questions, follow-up questions, requests for clarification, requests for additional data, information. Those are the cycles that we’re going through.

We don’t have a way to predict how much further time it’s going to take. I know that’s what we all want to know. We all want to know the crystal ball, and we do too, but we simply do not have a way to predict how much further time it’s going to take at this point.

Noteworthy, we think, is that while we’ve been going through this very, very, very long process, there have been a number of really important developments taking place in the field, moving in our direction.