Replies to post #795610 on NorthWest Biotherapeutics Inc (NWBO)

[skitahoe]

Iron Mike, you could be right, but as I understand it, NWBO's filing was largely made by contractors with expertise in such filings, NWBO certainly didn't have the staff to do it in house.

I would suspect that when questions were received, again they went to the contractors for assistance.

This process, no doubt, added delay as contractors probably didn't drop everything, the way employees may have, to answer regulators questions.

I doubt if we'll ever get the full story on what's taken so long. I do believe we'll get an approval, if the regulators didn't intend that they'd have kicked it back ages ago. If it's purely for GBM, we'll really never know if they looked at more.

On the other hand, it could be GBM alone, but with simultaneously approving the EDEN, then it may be the EDEN which caused the delay. Frankly, I agree with those who've said the EDEN wasn't necessary for GBM alone, but I don't know it hasn't been rolled in, or in some way tied up waiting for the EDEN.

Gary

[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