NorthWest Biotherapeutics Inc (NWBO)

[dennisdave]

I don't have an answer for why it's taking so long. Could be political landscape and risk. Could be NWBO just really screwed up the application. I can say with almost complete and entire certainty that it is not because the application has been updated to include scope (Eden, agnostic, etc) not specified in the original application. But you've got to realize there is a very real (some, including me, would say likely) chance that it's just going slow because NWBO's application was really, really low quality.

I don’t think Flaskworks was added to the MAA either more likely it was a parallel submission tied to the same regulatory package.
That would explain why Advent was named in the Feb 2024 PR as the entity to perform the validation runs and submit data “to regulators for approval to use the system.” It’s reasonable to think MHRA might prefer to align both decisions (MAA + Flaskworks approval) so the commercial license reflects the final manufacturing platform. Whether that means waiting for Flaskworks before signing off the MAA or releasing both decisions at the same time... we’ll see.

As for the “low quality” theory: If that had been the issue, MHRA would have flagged it long ago through RFIs.
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