>Early approval will likely be for the unmet need of treatment failure patients.<
Likely may be too strong a word. I’m not sure the probability is better than even money for early (i.e. pre-phase-3 completion) approval.
>Telaprevir is clearly better than boceprevir in treatment failure patients.<
Based on the data reported to date, I would agree. But the competitive landscape can change in a hurry, as you saw today in the treatment-naïve setting.
Inasmuch as Telaprevir and Boceprevir have essentially the same MoA, I can’t see any science-based reason why efficacy would be comparable in the treatment-naïve setting but Telaprevir would have much superior efficacy in the treatment-experienced setting. It may be that the yet-to-be-reported results in the treatment-experienced setting will exhibit regression to the mean and the two drugs will end up showing comparable efficacy in all settings.
Let’s talk biotech! “The efficient-market hypothesis may be the foremost piece of B.S. ever promulgated in any area of human knowledge!”
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