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Re: brooktrail1933 post# 609547

Thursday, 07/13/2023 11:18:04 PM

Thursday, July 13, 2023 11:18:04 PM

Post# of 705240
PDUFA dates are typically 6 to 8 months from BLA application acceptance not 12.

Rest of your argument just doesn’t make sense, but if I were you I would watch for their US manufacturing update first. They will let us know once CRL agreement has been signed. Then we can start speculating about BLA submission timelines. Until then there will be no BLA filing. And don’t worry you will also hear the management complain how much work it is to put together another million pages yet again (this time for the US application). And this will go on for a year or more, so you will have plenty of time to catch up!
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