CGTK is involved with all three. PIII for the PBG and CABG indications, and PI/II for the AV grafts for hemodialysis indication. It was the latter I was referring to; sorry if I was not clear about that.
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Your answer regarding real veins in good condition being preferred to artificial ones did help, though, thanks. Though the phrase "AV grafts are notorious sob's" leads me to ask "in what way, precisely (if different from the simple fact that so many eventually fail)?"
Also, I appreciate your reply regarding the information supplied by IVUS and by angiography. Since we're stuck with angiography as the determinant of the primary endpoint, do you have any insight on its ability to precisely measure the 75% occlusion ratio, differentiating well between patients with 74% occlusion and 76%? I would guess that the NDA would contain each patient's record, so the statisticians can look closely at the close calls, but . . . since the PII was single site, and the PIIIs are multi-site, we also have inter-site variability thrown in (hence my citation of the abstract concerning that issue in the Valuation post I made (adding the caveat that QCA -- the technique that is the subject of said abstract -- may not be the form being used here)).
TIA & Cheers, Tuck |
