Replies to post #691760 on NorthWest Biotherapeutics Inc (NWBO)

[dennisdave]

Went back to Q to look at true up case status, and just as I thought, it’s still in discovery. People on this board discussing possible court decision on that before end of June ASM are delusional.

exactly

[JFR161162]

Michael mener been on NDA.

[sentiment_stocks]

I’m thinking LG meant something else by his drop of the word “fall” in that word salad.

[learningcurve2020]

Yes, that's why they likely keep delaying the ASM but at some point they can't hold out anymore.


>>Went back to Q to look at true up case status, and just as I thought, it’s still in discovery. People on this board discussing possible court decision on that before end of June ASM are delusional.

[hankmanhub]

Reviewed 10q yet again to see why (a day b/4 10q came out) Les thought it might refer to a fall maa decision timeline,

My speculation is that NWBO received an RFI. In order to respond to this RFI, NWBO will need to present certain facts that will require an inspection(s) by the MHRA for verification. This IMHO are the (mysterious) inspections referred to on page 23 of the recent May 10 10Q. These inspections will need to be scheduled by NWBO and MHRA and create some delay, and thus the fall date for the MAA predicted by Les on the Biz show.

[Doc logic]

flipper44,

Two things about your observations. One is that it sure seems like approval for artisan only should have come much sooner IF all necessary obligations for approval could be met. My GUESS is that the product release qualifications could not be met at the level needed to meet expected demand. The Q points to quality validation not being able to be time, personnel or cost effective without Flaskworks and digitization creating an exemption pathway.
This leads to the second point which is that the first GMP Flaskworks unit is to be installed next month according to Les. Will the C suites be completely installed by then? If not then that unit could likely be placed in a B suite setting allowing for approval of artisan fitting out while Flaskworks finishes up and doing ongoing comparisons between Flaskworks and artisan. Getting completely fitted out likely points to Fall validation and certification of Flaskworks production as the primary method unless installation can happen sooner. The question for me is whether or not MHRA will grant a temporary or permanent backup approval based on the artisan method and patient need before that time while final fitting out, testing and inspections are being done. If so, any earlier approval is not out of the question and is reasonable to talk about. Best wishes.