Replies to post #382 on 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.

[DewDiligence]

DIC Timeline

>I am trying to get a grasp on when the LEO PIII might end.<

Although Leo is exclusively running the phase-2 DIC trial, we don’t yet know whether GTC and Leo will proceed jointly or separately in phase-3. For the sake of this discussion, let’s assume that GTC proceeds separately.

Since we broached the DIC timeline on this board about a year ago, it has slipped somewhat because Leo took longer than expected to commence the phase-2 trial. Here’s my best guess for how things will unfold:

Aug 07: Enroll first patient in phase-2 (#msg-21836554).

Jun 08: Enroll last patient in phase-2.

Sep 08: Complete treatment and 90-day follow-up for all patients in phase-2.

Feb 09: Complete phase-2 data analysis and end-of-phase-2 meeting with FDA, settling on a design for phase-3 trial(s).

Mar-Jun 09: Set up clinical-trial sites for phase-3.

Jul 09: Enroll first patient.

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

1H11: Submit BLA.