>VRTX – In all seriousness, considering they have improved HCV treatment by a factor of 3+, (for the worst version of HCV) they should be granted FDA Approval without further studies, other than post-marketing studies/additional safety studies.<
In effect, the Telaprevir phase-3 studies in the treatment-naïve setting will now become safety studies because the efficacy as measured by SVR is unlikely to change materially relative to PROVE-1/PROVE-2.
(Antiviral drugs are a notable exception to the ravages of program-survival bias!)
The treatment-refractory setting, which PROVE-3 is testing, is another story, of course. We do not yet know how well Telaprevir will work there.
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