GTC Biotherapeutics (fka GTCB)

[DewDiligence]

>DIC PIII: I am trying to get a grasp on when the LEO PIII might end. Would 4th qtr 2008 be appropriate?<

That’s too tight, IMHO. Let’s assume for the sake of discussion that: 1) Leo starts the phase-2 trial around the end of 2006; 2) Leo enrolls 200 patients in six months; 3) The primary endpoint is mortality at 90 days with no additional follow-up beyond that; 4) Six months are needed to analyze the data, complete an end-of-phase-2 meeting with the EMEA, and gain approval for the design of phase-3.

The above assumptions with no additional slack place the start of a phase-3 DIC trial in late 1Q08 or early 2Q08. Hence I do not see how phase-3 could be all done by 4Q08.