Replies to post #13443 on GTC Biotherapeutics (fka GTCB)

[DewDiligence]

Rough Timeline for ATryn DIC Program

[Updated for the temporary halt in phase-2
patient enrollment while Leo and LFB negotiate
the transfer of GTC’s license from the former to
the latter (#msg-33294645). I’ve added six
months to all future entries in this post, which
is my best guess for the impact of the delay.]


Aug 2007: First patient enrolled in phase-2 (#msg-21836554).

3Q09: Enroll last patient in phase-2.

1H10: Complete treatment and 90-day follow-up for all patients in phase-2; report phase-2 results.

2H10: Hold end-of-phase-2 meetings with EMEA and FDA, settling on a design for phase-3 program.

1H11: Set up clinical-trial sites for phase-3 trial(s) and enroll first patients.

1H12: Complete phase-3 trial(s).

2H12: Submit regulatory applications to FDA and EMEA.

2H12/1H13: Possible FDA advisory panel.

1H13/2H13: Decisions by FDA and EMEA: 1H13 if priority review, 2H13 if standard review.