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DewDiligence

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DewDiligence

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Re: DewDiligence post# 6309

Thursday, 08/07/2008 10:30:46 AM

Thursday, August 07, 2008 10:30:46 AM

Post# of 19309
Rough Timeline for ATryn DIC Program

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


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

Early 2009: Enroll last patient in phase-2.

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

1H10: Hold end-of-phase-2 meetings with EMEA (Leo) and FDA (GTC), settling on a design for phase-3 program.

2H10: Set up clinical-trial sites for phase-3 trial(s) and enroll first patients.

2H11: Complete phase-3 trial(s).

1H12: Submit regulatory applications.


Let’s talk biotech!
“If your beloved drug candidate sounds
too good to be true, it probably is.”

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

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