NorthWest Biotherapeutics Inc (NWBO)

[froggmister]

Of course the JAMA article isn't sufficient for approval. To borrow a phrase from LL, it's necessary but not sufficient.

Nevertheless, please explain how MHRA will reject DCVax-L considering:

Nov 2022: JAMA confirming efficacy, and 94 neuro-oncologists disagree with you that efficacy cannot be confirmed because of the change in the SAP and the confounding nature of the trial. But let's really stretch it and say they are wrong and you are right. If that's true, how does this timeline make sense?

Jan-March 2024: MHRA accepts application. If trial was confounded, would they accept? Let's say yes, and they want the Commission for Human Medicines (CHM) to weigh in.

July 2024: CHM considers DCVax-L. If they determine trial is confounded, why move past this stage?

Oct 2024-Jan 2025: Multiple sources confirm inspections. Why are we inspecting the manufacturing facility and the trial sites, spread out all over the world, if the trial is confounded and has no chance of approval? What a colossal waste of resources.

The idea that the change in the trial SAP makes this unapprovable in light of these events seems, um, unlikely.

Place your bets.