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Re: iwfal post# 68207

Wednesday, 11/05/2008 2:44:47 PM

Wednesday, November 05, 2008 2:44:47 PM

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ZGEN – I would expect the FDA’s guidance for phase-3 to consist of one RCT and one open-label safety study—similar to what the FDA is requiring for Telaprevir in the first-line setting.

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