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DewDiligence

07/08/08 9:45 PM

#12726 RE: vinmantoo #12723

>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.