NorthWest Biotherapeutics Inc (NWBO)

[FeMike]

The July 15 NICE letter states that NWBO is still fully occupied and engaged with the MHRA and not yet in a position to submit to NICE. NICE also says they are awaiting further contact. That confirms the MAA is active and that the company hasn’t reached the handoff point. At this late stage of a review, that remaining step is almost always the finalisation of the SmPC.

Here is what I want you to answer for me slAIve

These 'confirmations' were true exactly one month ago.

NWBO was actively engaged with the MHRA, and they were not in a position to submit the evidence package.

Why, one month ago when these circumstances were true, were they not approved and in labeling? Two months ago? What has changed in the past month that these statements now confirm approval/labeling, when they did not mean that one month ago? Is 18 months post submission not considered "this late stage of a review" but 19 months post submission is considered "this late stage of review"? What milestone has been hit?

Let me break it down for you another way since you are slow. These are the parameters you are basing your thesis off of:

March 15th, 2024: NWBO is actively engaged with the MHRA, cannot submit evidence package, MAA under review
September 15th, 2024: NWBO is actively engaged with the MHRA, cannot submit evidence package, MAA under review
January 15th, 2025: NWBO is actively engaged with the MHRA, cannot submit evidence package, MAA under review
March 15th, 2025: NWBO is actively engaged with the MHRA, cannot submit evidence package, MAA under review
May 15th, 2025: NWBO is actively engaged with the MHRA, cannot submit evidence package, MAA under review
June 15th, 2025: NWBO is actively engaged with the MHRA, cannot submit evidence package, MAA under review
July 15th, 2025: NWBO is actively engaged with the MHRA, cannot submit evidence package, these two facts mean that the MAA is now approved and in labeling

Sooo....what am I missing? What has changed beside the date? Is your conclusion purely based on your belief that "surely, this can't possibly take any longer"? You must tell me what else has changed besides these "facts" you've laid out.