Replies to post #795646 on NorthWest Biotherapeutics Inc (NWBO)

[FeMike]

Those performance stats only track standard chemical or biologic applications not complex ATMPs that involve ongoing GMP validation. ATMP reviews routinely fall outside those public “performance metrics” because those metrics measure clock days, and MHRA pauses the clock whenever the sponsor is completing regulatory tasks (like Flaskworks validation data).

So the absence of a “backlogged” entry doesn’t disprove anything, it just means this review remains active with supplementary data pending, which is completely normal for ATMPs.

I don't have the MHRA background to contest this but, assuming it's true, that's fair enough and a decent explanation for the seemingly blatant absentee from MHRA's MAA metric pubs.

WRT the progress of the Flaskworks unit, I just have to disagree. I'm not saying you're wrong, just that I disagree. The timeline seems extremely optimistic if you are right.

As of the last 10Q, as you quote, they had not begun building out the Grade C labs. They designed and negotiated construction to begin in the third quarter, so construction may well be ongoing now, but it's extremely unlikely it is completed. As such, the production/delivery of the GMP units have almost certainly not occurred yet. Then, once they are produced and delivered, the validation runs have to take place which isn't a short process either. Procedures, audits, equivalency etc all have to occur which is multi-month. NWBO will run the tests and do internal audits before the MHRA qualification process even starts.

So yes, while it's plausible, I don't think the Grade C labs are even finished yet (why would they not PR this?), much less the GMP flaskworks units delivered, much much less the qualification started. So if MAA is waiting on that entire process, I think you're looking at Q1 '26 at the absolute earliest for a decision, and in my estimation Q2.

I think NICE application could be waiting on that. I really hope not the MAA decision.