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Re: Blackpool post# 823403

Wednesday, 04/29/2026 6:49:38 AM

Wednesday, April 29, 2026 6:49:38 AM

Post# of 826128
It’s a question of stage. It could sound endless, but the MHRA process is an external time keeper, so it’s not endless.

Even entering the MHRA process demonstrated some belief by NWBO (and I believe their less formal discussions with nice/mhra) that they were mature enough to engage in the maa process — albeit, w/my rearview vision, I think they knew they’d need more maturation within the maa process than most, and their definition of clock on and clock off would resemble a warped clock in a surrealist painting.

So what did George Z mean that full versus conditional approval was left to be determined? It comes down to stage, and the stage is 153 calendar days post likely successful second CHM.
The science is good, the new regs are activated, the manufacturing is a go, the initial external leukapheresis clinics are already contracted and trained with a larger NWBO leuk clinic being prepared inside a hospital for further expansion. IMO.

Well, what are we waiting for?
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