Replies to post #4715 on 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

[ThomasS]

O.K., without using Ketamine as an example, if GTC's cheaper version of Factor VIIa could be used in heroic life-saving settings such as blood substitutes have, I imagine the various militaries would give audience and "establish" a pathway.
Whether a "biologic" or traditional "drug" is mere verbage when heroic life-saving is concerned.
When considering the body of research available, this is viable IF LFB/GTC can provide quantities en masse cheaply.

"About 50% of combat deaths are due to fatal bleeding. The aim of this analysis was to assess the efficacy and safety of recombinant activated factor VII (rFVIIa; NovoSeven, Novo Nordisk A/S, Bagsvaerd, Denmark) when used to treat trauma-related blood loss."

"RESULTS: Haemostatic efficacy was achieved in 43/45 (95.6%) patients following rFVIIa administration, and transfusion requirements (defined as median units of packed red blood cells administered in the 24-hour period following rFVIIa administration) were reduced from 10 to 3 units (P < 0.001). Coagulation status also showed improvement (median values for activated partial thromboplastin time and prothrombin time decreased from 43 to 37 s [P < 0.001] and from 19 to 12 s [P = 0.026], respectively). No safety concerns were raised by the available data."