RE:RE:RE:RE:PROMETIC ANNOUNCES FDA ACCEPTANCE OF ITS BIOLOGICS LICENSE AThis is THE best case scenario playing out!
The BLA acceptance and PDUFA date issuance is a huge milestone and de risker, the analysts and institutions will be all over this. All the worry and Rumour momgering on the street about a rejection letter and other BS is completely dispelled with this news.
the PDUFA date represents the absolute “end date” meaning the FDA will Render its decision between now and then. Given how supportive the FDA has been with the Fast track designation and the Pediatric Designation, smart money will be betting on an formal approval in the next 60-90 days... and very likely to include a Pediatric Voucher
This is a smart money catalyst, analysts and institutions will be all over this today. Expect a big up move on big volume. Have fun, and stay long its just beginning