[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.
“The efficient-market hypothesis may be the foremost piece of B.S. ever promulgated in any area of human knowledge!”
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