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Re: dennisdave post# 569597

Tuesday, 02/21/2023 5:49:36 PM

Tuesday, February 21, 2023 5:49:36 PM

Post# of 826052
I don't know much about the MHRA because the process is hardly ever mentioned by US biotechs. The manufacturing detail is part of the US FDA BLA.

I don't see why the MIA isn't much the same as the FDA BLA. The MIA would be piece of the overall MAA. The only time i ever heard of this seperation/pre-requisite is from NWBO.
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