Well...
If MSB had simply stamped "Resubmit" on the BLA in Jan 2022, it would have been resubmitted without:
A manufacturing facility inspection
Stock on shelf potency assay re-testing
Long term GvHD survival data
Confirmation that Jakafi Failed to improve mortality in their confirmatory study.
So old Bean, I'd say congrats to MSB will be in order, for not rushing it through and lowering the chances of approval.
Clearly they know a lot, lot , lot more about the approval process than a no name, non holding 10 post per day nobody on hot copper.
Now your suggesting it should have been resubmitted in under 6 weeks from the CRL....give up for everyone's sake.
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