GTC Biotherapeutics (fka GTCB)

[DewDiligence]

>Perhaps GTC should appeal to the military upon advancing to PI to subsidize additional trials/expedite emergency stockpiles, etc. JAV's Ketamine product doesn't even require PIII's due to the military setting/emergency rooms.<

Please elaborate. My impression was that JAV’s Ketamine for analgesic use in the military/ER setting would be submitted to the FDA under Section 505b2, which applies to reformulations of approved small-molecule drugs. There is as yet no such approval pathway for biologics.