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DewDiligence

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DewDiligence

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Re: DewDiligence post# 5128

Friday, 10/12/2007 8:08:24 AM

Friday, October 12, 2007 8:08:24 AM

Post# of 19309
ATryn DIC Timeline

[Updated to conform to the chart in #msg-23625770.]

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

Mid 2008: Enroll last patient in phase-2.

Late 2008: Complete treatment and 90-day follow-up for all patients in phase-2; report results.

1H09: Hold end-of-phase-2 meetings with EMEA (Leo) and FDA (GTC), settling on a design for phase-3 trial(s)*.

2H09: Set up clinical-trial sites for phase-3 trial(s)* and enroll first patients.

2H10: Complete phase-3 trial(s)*.

1H11: Submit MAA (Leo) and BLA (GTC).

*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.

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

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