Merck Went Own Way On Bezlotoxumab Endpoint And FDA May Not Follow

This article was originally published in The Pink Sheet Daily

07 Jun 2016
News

Brenda Sandburg @brendasandburg Brenda.Sandburg@informa.com

Executive Summary

Merck rejected FDA's recommended endpoint to show efficacy in preventing C. difficile recurrence, which could make it difficult to gain approval for the product, headed to June 9 advisory panel review.

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Merck Went Own Way On Bezlotoxumab Endpoint And FDA May Not Follow

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Executive Summary

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