News Focus
News Focus
icon url

DewDiligence

10/25/13 9:23 AM

#168779 RE: ronpopeil #168778

GILD now has a Sofosbuvir pricing dilemma re GT2 vs GT3!
icon url

DewDiligence

10/25/13 3:16 PM

#168792 RE: ronpopeil #168778

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.