Replies to post #569706 on NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

Why don’t you tell Les to get off his ass and put their explanation in a PR instead of jerking you around on the phone?

[Doc logic]

sentiment_stocks,

The various points of reference based on circumstances do point to having both an MIA and MAA in process even if neither is fully complete based on them both being approvable. The other issue is that there could be side by side submissions being worked on with the artisan method and the Edens method. In this case an approved but not technically finalized or desired for end use process could be utilized to begin the MAA process based on an interim MIA approval with the potential switch to the other process based on qualifying it prior to an announcement of MAA approval. Convoluted? Maybe but seems doable and not too much unlike the FDA process. Would NWBO announce this? Probably not as they would want to announce MIA acceptance for Edens first if possible. The technicality comes with any bridge MIA under the artisan method needing to be approved first to get things rolling even if both MIA approvals for different methods and the MAA approval might be announced nearly simultaneously later.
I think biosectinvestor has a better handle on the realities and ILAP process but if what I mention is really possible then it might even be likely. Best wishes.

[dennisdave]

an approved MIA in the module?

The whole point that is being made is that there is no need for an approved MIA aka HMRA rule as long as a request for MIA has been made.

Is the MAA considered complete and ready for the 100 day Final Phase without

A normal and logical thinking person would say of course 2.5 years after data lock. But you should not ask a normal and logical thinking when it comes to NWBO