NorthWest Biotherapeutics Inc (NWBO)

[FeMike]

Now here is the contradiction: GZ has explicitly confirmed to me that manual production is (in his view) the intended commercial route.
That statement is directly at odds with what the MHRA says — and with reality. If Flaskworks were not the intended commercial route, the entire closed automated system would be economically and strategically pointless. Everyone understands this. You don’t build Flaskworks for fun.

I do not know the answer to this, and I'm not saying you are wrong, but I do think you are failing to recognize the distinct possibility that both manufacturing methods are viable commercial production routes.

Capacity is much lower, but it still exists, with the Grade B room and artisan manufacturing method. It is a viable route to commercial production and, as such, the MA can be approved based on that. It doesn't matter that NWBO is hopeful to switch to another manufacturing process within possibly months of an approval decision.

MHRA's statement says:

We generally cannot grant an MA based solely on the original process if the applicant no longer intends to use it.

I don't believe that is the case. NWBO has explicitly stated on numerous occasions that initial rollout and commercialization will be done with artisan method. Just because that initial period has decreased from a couple years to potentially 6-9 months, doesn't mean they don't still intend to use it to bridge the gap.

NWBO intends to use artisan until Flaskworks is ready, at which point they intend to switch. So if the MHRA's general guideline is that they can't grant the MA based on the original process if the applicant no longer intends to use it, I think it's safe to say that when they ask NWBO this question, the company's answer will be "Yes, we intend to use the artisan 'original' process to manufacture this commercially". Which is true, they do intend to use it, until a more economical and efficient method becomes available.

That's my opinion of the situation. I certainly see your angle, though, and don't discount it as a possibility. I'm just not sure the evidence you've given means 100%, beyond a shadow of a doubt, NWBO has to get Flaskworks validated before the MAA will be decided.