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Re: mskatiescarletohara post# 31904

Wednesday, 07/26/2006 6:07:22 PM

Wednesday, July 26, 2006 6:07:22 PM

Post# of 257259
Re : VRTX >>>It appears VRTX now has cash on hand to aggressively enroll their Phase II studies, and perhaps even move into pivotals by 2008.I wonder if the FDA is going to grant accelerated approval for treating naive patients on the basis of the two Phase II studies. <<<

I think VRTX is just about counting on approval based on the PII studies. With 1000 patients in total they should have enough to demonstrate safety , and if they get the efficacy they expect the individual arms should generate statsig results. With SVR numbers > 80% or so in Gen 1 patients I think the FDA would be inclined to view early approval favorably.

BTW , Dew , I was only kidding about the CC , though I do appreciate your summaries. I'll listen to the VRTX replay when it comes up as I missed the start of the call at 5.

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