Anyone have a view on whether there will be notification of
Receipt of the BLA
Acceptance of the BLA
Meso has updated re refiling this quarter so my view is they don't have to announce lodgement
But acceptance of the resubmission? Notification of Class 1 or 2 - this would need to be announced................
Why my queries? Sufficient to refile - not resubmit- is the same BLA being refiled with the additional potency data attached?
With apparent strong verbal cues from the FDA do we dodge prior SOP? Why would they need 30 days to accept a resubmission they already accepted? Then the one thing that caused the CRL appears to be sufficiently addressed
My musings- maybe I'm going mad
Reg
Anyone have a view on whether there will be notification of...
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