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exwannabe

10/15/22 3:56 PM

#522174 RE: biosectinvestor #522171

1) the relevant and largest parts of an application for approval are already pending with at least one regulator and given the nature of new rules, likely multiple regulators, a key indicator;


The largest and most relevant part of the application process if by far the MAA/BLA.

The PIP is a nit. Just a checkbox to be ticked on the way., And they had a commercially approved CDMO years ago.

There is no indication an MAA.BLA has been filed, and plenty of reason to assume it has not been.