GTC Biotherapeutics (fka GTCB)

[DewDiligence]

Rough Timeline for ATryn DIC Program

[Updated for the latest enrollment guidance. Other than the first two items below, the dates are my own guesses rather than GTC’s guidance.]

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

End 2008: Enroll last patient in phase-2.

1H09: Complete treatment and 90-day follow-up for all patients in phase-2; report results.

2H09: Hold end-of-phase-2 meetings with EMEA (Leo) and FDA (GTC), settling on a design for phase-3 trial(s)*.

1H10: Set up clinical-trial sites for phase-3 trial(s)* and enroll first patients.

1H11: Complete phase-3 trial(s)*.

2H11: Submit regulatory applications.

*Subject to feedback from the EMEA and FDA, Leo and GTC may decide to run an integrated global phase-3 program rather than separate programs for the EU and US.