GTC Biotherapeutics (fka GTCB)

[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.