Thursday, October 20, 2022 3:05:04 PM
When they make a submission they don't announce it, if it's accepted, then they announce it. If the regulator doesn't accept it, they'll provide guidance on what needs to be changed, they make the change, resubmit, and wait to see if the get an acceptance. Again, they only announce the acceptance.
Well this is just patently false.
Companies very regularly, I’d say more often than not, announce submissions of BLA’s/MAA’s.
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