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FDA Changed Course On Zontivity Because Of Skepticism Of Subgroups At High Levels

Executive Summary

Large, complex dataset supporting Merck’s vorapaxar NDA invited “slicing and dicing” of the data by the primary reviewers – and made weight-based restrictions a key issue at the late-cycle and advisory committee meetings. But unusual, late-in-the-game reviews by high level FDA officials led to a post-panel U-turn.

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