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antihama

07/12/23 5:49 PM

#609036 RE: Maverick0408 #608891

Yeah, I have to agree w you. NWBO and its consultants (eg equivalent to a VP and/or Director of Manufacturing/Regulatory/QA/etc) are handling the MAA. Advent is not a consultant, they are the third party manufacturer/CDMO/CMO although you can think of them as the consultant putting together the Chemistry, Manufacturing, and Controls (CMC) module.