Hi there,
The FDA is Government - it needs to have something bureaucratic to work with. At the moment, the last CRL completed a full administrative process on the previous application.
So, the FTA now needs a new application to work with I.e. a resubmitted BLA, so that it can give an approved.to something.
hope that helps.
Cheers
Hi there, The FDA is Government - it needs to have something...
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