Replies to post #795631 on NorthWest Biotherapeutics Inc (NWBO)

[FeMike]

All inspection rounds and RFIs were completed months ago.
Any major deficiencies would already have been addressed you don’t spend nearly a year post-inspection in silence just because of poor paperwork.
That’s simply not how the process works IMO

Eh, if that's true, this application should be backlogged and counting against MHRA's performance metrics. We don't see that. That pretty patently disproves this theory. I'm not saying the RFI's aren't complete, but if they are it wasn't "months" ago. Plus if you look at NWBO's own estimations of the process, the Flaskworks unit still shouldn't be ready for approval. We'll find out more on that in the 10Q in 2 weeks, but I don't think that's approvable quite yet.

I think the aspect of Eden/flaskworks manufacturing is well enough decoupled from the MAA. My estimate is they are going to approve the MAA on artisan, then over the next (few?) months, Eden manufacturing will be ready/approved, then the NICE application will be submitted for Eden and not artisan.