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Re: kabunushi post# 710825

Monday, 08/05/2024 10:31:41 PM

Monday, August 05, 2024 10:31:41 PM

Post# of 827614
Right kab, apparently the MHRA doesn’t officially confirm on which pathway the application is being reviewed, but as I said, I think Northwest Bio does actually know that it’s under an accelerated priority review.

As far as the number of site visits, my speculation would be a handful at most. I know the FDA physically inspects a little over 1% of clinical trial sites, so my assumption is that the MHRA is somewhat similar. And yes, we know that preparation is key, and it sounds like Northwest Bio and their contractors spent significant time and resources to ensure that every site was very well prepared.
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