Share
clock Created with Sketch. 23/07/24
16:26
Share
Originally posted by otherperspective:
↑
Good news. This has been a rolling submission and the OTP has had plenty of time to opine on the additional potency assay should it really have not been fit for purpose. A Class 2 is anything from 2 months UP to 6 months, but as so many key parts have already passed review, such as manufacturing PLI, safety, efficacy and advisory panel, I would be surprised if this is not all wrapped up by early November because the resubmission is supposed to focus primarily on the outstanding items from the previous submission plus about a month to agree labelling and post approval commitments.four year mortality data almost double that of treatment alternatives at 49% of a largely severe grade patient population, this all looks pretty academic to me. Passing the pre license manufacturing inspection makes it very difficult to argue with batch variability , purity and consistency. I would give this a 95%+ chance of approval now it has been accepted . Remember, the EAP and virtually every validated biomarker (or combinations with Minnesota high grade) back up the clinical evidence. If the FDA had any real doubts they could have just pushed Mesoblast to reapply under accelerated approval pathway…which the Company had previously offered to do !
Expand
I think there is a high chance that the FDA approve this however didn't the last BLA submission address CMC issues and that was accepted - ultimately met with a CRL?
(20min delay)