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Better Late Than Never: “Breakthrough” Status Aided Sovaldi’s On-Time Approval

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Although Gilead’s hepatitis C drug picked up the “breakthrough therapy” moniker with just two months left in the NDA review cycle, the designation enabled FDA staff to analyze new VALENCE and PHOTON-1 trial data and still approve sofosbuvir by the PDUFA goal date.

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