realstocky wrote: We're at stage to place your bets, big players did yesterday where the sp hit near 5$, first week of june trading could be 10 to 15$...on FDA ok....
FDA granted ALREADY ORPHAN STATUS to riplazym... voucher with FDA ok will be worth around 120M$ automatically 1st week of june.
...we get 70% of that, Kedrion takes care of everything else, commercialisation, expenses etc,
+17M +5M, total value of deal is more than 100M$ to LMNL. (NR yesterday)
106M$ inflows to LMNL...
Through its’ US subsidiary, Prometic Biotherapeutics Inc., the Company has resubmitted a BLA in September 2020 with the FDA seeking approval to treat patients with C-PLGD. The FDA confirmed that the resubmission is a complete, Class 2 response to the complete response letter issued in 2018 and has provided a Prescription Drug User Fee Act (“PDUFA”) target action date of June 5, 2021.
Ryplazim® has previously been granted Orphan Drug and Rare Pediatric Disease Designations by the FDA for the treatment of congenital plasminogen deficiency. ====>voucher:)