GTC Biotherapeutics (fka GTCB)

[dewophile]

I wasn't under the impression JAV was pursuing ketamine under 505b2 because it is only approved in anesthetic doses, and JAV is pursuing analgesic dosing for which there is relatively limited data and experience to support a 505b2 pathway..regardless it seems the military was instrumental in swaying the FDA to accept the "phase 2" data on analgesic dosing as adequate for an NDA