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Truvada Pre-exposure Prophylaxis Claim Must Overcome Conflicting Subgroup Data

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA’s Antiviral Drugs Advisory Committee will have to wrestle with the same types of questions about efficacy across various populations and implications for real world use that were raised by the AIDS Healthcare Foundation in a recent citizen petition opposing approval of Gilead’s sNDA for the new indication.

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