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DewDiligence

04/29/13 1:43 PM

#160456 RE: oc631 #160455

GILD—Could failure to achieve GT3 labeling for Sofo/Riba, within the pooled data filing, delay approval for GT2 patients? Is it possible GILD would be required to refile the Sofo/Riba NDA for GT2?

I don’t think so. The data appear solid enough in GT2 to warrant approval on the current review cycle.