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Re: Doc logic post# 373444

Thursday, 04/29/2021 4:30:35 PM

Thursday, April 29, 2021 4:30:35 PM

Post# of 730757
"Manufacturing, manufacturing, manufacturing. Getting the Flaskworks process in place for the BLA is the most obvious reason for delay with timing details being worked out potentially with Merck being another."

Commercial (post approval) manufacturing issues are not part of the BLA. Methods used to produce product using in the trial of course is part of the BLA> Manufacturing approval is a completely separate approval process.
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