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Re: iwasadiver post# 384376

Sunday, 06/13/2021 7:56:09 PM

Sunday, June 13, 2021 7:56:09 PM

Post# of 721088
Diver,

It's my belief that in a rolling BLA the portion submitted is under review, and if something is found wanting, the company is afforded the opportunity to cure the problem. Others here seem to be saying the opposite, if there is a problem, it remains a problem. I'd like to hear your, or others with some expertise opinion of the advantage of the rolling BLA.

As I see it, a rolling BLA is an opportunity to work with the FDA on the submission, it should result in an expedited review. If I'm wrong about that please explain the advantage of it.

Gary
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