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Posted On: 09/20/2019 11:29:07 AM
Post# of 150948
Quote:
Approval process may take 2 months this or that way , but there is a legal time limit for it...
There is no response to the BTD request.
Someone posted legal time limits before - FDA must acknowledge completeness of a BLA within 2 months and it could take another 6 months for a response. Please, correct if these timelines are incorrect or different for a rolling BLA.
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