GTC Biotherapeutics (fka GTCB)

[biopearl]

Flo I agree. Especially since the trial was continued in open label fashion which means I think that patients enrolled can continue to have access to the drug. Correct me anyone if this is not correct. My question is that if safety and efficacy endpoints are met, and say for the sake of argument that the study was DRAMATICALY positive, could the FDA forego a phase III and go say to a post market study (phase 4)? Here's another hypo, if the Phase II DIC trial shows statistical significance before the study ends, would it have to be completed or could Atryn be marketed or again evaluated with a phase 4, skipping the need for a phase three study. Dr. Cox has already laid the groundwork for dissappointingly slow enrollement in the DIC study. bp