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Re: Doc logic post# 413358

Thursday, 10/28/2021 9:30:33 PM

Thursday, October 28, 2021 9:30:33 PM

Post# of 700720
Doc logic: Great questions, I am not sure. However, given that the MHRA inspection was recently completed well past the stated MHRA stated 90 working days) I have been trying to figure out if it was possible for NWBO/advent to modify the May 7th GMP application to add the "Flashworks process"?

My question is if NWBO/Advent were aware of the MHRA delay in the timing of inspection AND the MHRA would allow additions to the application, then there was a window of time when Flashworks could have been slipped in. I highly doubt this scenario could happen because the MHRA would have to keep NWBO/Advent in the loop for schedule and allow modifications to the submitted application while in queue.

Hindsight is always 20/20. Peace.
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