GTC Biotherapeutics (fka GTCB)

[DewDiligence]

>That is a bit negative since it gives the impression that Ovation isn't sure enough about FDA approval of rATIII to start the trial up now. I would feel better if Ovation said they were trying to meet with the FDA quickly to get an SPA worked out so they can begin the trial ASAP.<

Actually, Ovation is trying to get feedback from the FDA on what should go into an SPA for CABG/HR; this aspect of the planning for the CABG/HR indication need not wait for FDA approval in HD.

What does need to wait for FDA approval in HD is the opening of trial centers for CABG/HR and the beginning of patient recruitment. In other words, the delay with respect to the CABG/HR indication is probably not as long as what you thought.