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Re: dewophile post# 167668

Monday, 10/07/2013 1:52:16 PM

Monday, October 07, 2013 1:52:16 PM

Post# of 257268

ABBV/ENTA—from a competitive and commercial standpoint if they felt they wouldn't do well [without ribavirin], i am not so sure they would run these arms [in PEARL-2/3/4].

Again, my view is that some arms of some of the registrational phase-3 trials had to exclude ribavirin. Think of the problem ABBV/ENTA would have had convincing advisory panelists and the FDA that ribavirin was an obligate component of the regimen if the phase-3 program hadn’t even tested that hypothesis.

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