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Re: biosectinvestor post# 522171

Saturday, 10/15/2022 3:56:31 PM

Saturday, October 15, 2022 3:56:31 PM

Post# of 818870

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.
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