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Re: ronpopeil post# 168778

Friday, 10/25/2013 3:16:47 PM

Friday, October 25, 2013 3:16:47 PM

Post# of 257257
GILD—The “new data” on 16w of treatment with Sofosbuvir + ribavirin in treatment-naïve GT3 was not real data from a clinical trial, but rather a mathematical extrapolation by the FDA of GILD’s phase-2 data in treatment-experienced GT3 patients (see page 8 of the FDA briefing doc at http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AntiviralDrugsAdvisoryCommittee/UCM371876.pdf ). This nuance was missed by the streams I follow on Twitter.

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