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.