The real test will be in 2 weeks when the FDA reply and say YES or NO. For now, the BLA is finally resubmitted, but the real test will come from the confirmation from the FDA in 13 days from today.
The Company further believes that the amended BLA represents a Class 2 resubmission that would provide for a Prescription Drug User Fee Act (PDUFA) date for FDA review and action within six months from the date of the resubmission. Pending confirmation from the FDA that the resubmission addresses the issues raised in the CRL, current published guidance from the FDA is that they will indicate the new action due date in writing to the Company within 14 days of receipt of the BLA resubmission. The FDA previously granted Orphan Drug and Rare Pediatric Disease Designations for Ryplazim® for the treatment of C-PLGD.
If it is a no, this goes down the drain.
If it is a yes, then there will be a new PDUFA in less than 6 months. Then I believe the stock will pop to the recent high.
Over the last 15 years, BLA resubmission after a CRL concerning CMC problems were approuved in way less than the new 6 months pdufa since a large portion is already revised by the FDA.
However, with the covid and the election in USA and the fact that LMNL resubmit the BLA for more broader use than the initial BLA, we will have to wait and see.
But for now, the next and very important milestone is in less than 2 weeks.