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Re: iwfal post# 152243

Monday, 11/12/2012 11:18:53 PM

Monday, November 12, 2012 11:18:53 PM

Post# of 257266

ABT…no SOC treatment arm. Approvable?

Yes, IMO. I noted in #msg-81414058 that the SAPHIRE-III and -IV studies are +/- ribavirin and lack a traditional control arm, while the SAPHIRE-I and -II studies have placebo control arms (with deferred treatment on non-placebo regimens).

It’s the totality of ABT’s phase-3 program in genotype-1 HCV that you should be critiquing, not one or two trials in isolation.

p.s. The trial you linked to is SAPHIRE-I.

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