NorthWest Biotherapeutics Inc (NWBO)

[biosectinvestor]

Correct. The RA’s have already agreed and approved of the ECA and endpoints and prior to data being locked. That is clear. The only thing that is ever in nuclear is regulators always, no matter when you got approval, no matter what pains you went to to get even a special protocol assessment, can change their mind.

That’s just the nature of drug regulation. If there is something unsafe particularly, or something that really doesn’t add up to the conclusion, they can always ask for more. Personally, I don’t see anything raised in any context that suggests they would have such a concern. Yes, there were complexities with the trial and they will all likely aggressively ask questions and even have some questions outstanding.

But the data looks extremely strong, the safety is unquestioned and the actual surviving patients unquestionable. This looks to me, at the end of the day like some form of marketing approval and, in truth, a slam dunk. That’s all just IMHO.