NorthWest Biotherapeutics Inc (NWBO)

[Doc logic]

AllSheWrote,

With all due respect opinions without actual evidence don’t matter, mine or yours included. I have JAMA and a bunch of living patients as proof that the treatment works. I have the pathway of exceptions to adequate and well controlled studies as the backdrop for how the post trial moves are explained including the SAP and acceptance of same by the regulators which includes dropping PFS because of pseudoprogression with no adequate substitute and the OS primary change to comparison against external controls instead of early treatment crossover patients because of crossing over to an active comparator.
I have the desire by regulators for closed system operations during manufacturing on my side for a push for this before approval in any jurisdiction because of NIH’s experience with contamination in albumin in an open processing system.
Artisan manufacturing has been around for decades and Flaskworks is still not validated as GMP ready by NWBO yet. MHRA can express legitimate safety concerns about any open manufacturing process with cell therapies and likely had questions related to this in the CMC portion of the MAA submission that deals with it. This of course is speculative but manufacturing for commercial scale purposes is really kind of a big deal and has been a big reason why some promising treatments never were approved so if MHRA wants proof that a GMP closed system is being put in place they might have wanted a GMP compliant model to base any approval on or give a conditional approval based on one being presented by a certain time. Best wishes.