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Mortality Vs. Clinical Cure: Telavancin Review Expected To Renew Debate On Nosocomial Pneumonia Endpoints

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA’s Anti-Infective Drugs Advisory Committee will take up Theravance’s Vibativ NDA on Nov. 29 following two “complete response” letters and the sponsor’s rejected requests for dispute resolution, in which it has argued it should not be held to the standards set forth in a 2010 draft guidance.

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