Replies to post #763976 on NorthWest Biotherapeutics Inc (NWBO)

[Galzus Research]

I don't. Much different process, and I'm not a regulatory professional on either side of the pond. I can offer these thoughts:

1) An early rejection would be for some kind of major issue with the application. The FDA's complete response letters that you usually see are related to manufacturing issues, which is one area where NWBO shareholders are digging up plenty of positive signals on. It "feels" weird to me that an application would be considered this long and then could be rejected outright. So I am not expecting that to happen.

2) I cannot recall a time where I saw a company withdraw their application for approval. I've seen accelerated approval NDAs be pulled when a confirmatory trial failed, but that's a different matter. I highly, highly doubt NWBO will withdraw their application, regardless of what they might be thinking about the status of the review.

Answers are coming soon enough one way or the other.

[learningcurve2020]

The app is likely in limbo probably because they’re still trying to figure out why maybe it’s helpful to a few but not the others? IF the app is even being considered, IMO the best you can hope for is some approval with restrictions that would include NICE payment for some subset. That’s what Liau is probably trying to figure out, IMO.