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Restanza Superiority Trials Intended To Avoid Non-Inferiority "Quagmire"

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Advanced Life Sciences CEO Michael Flavin decided a pair of superiority trials was the best way to prove the efficacy of the company’s Restanza in community-acquired bacterial pneumonia, given the "stalemate" at FDA regarding the use of non-inferiority trials in antibiotics.

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