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Eliquis Superiority Claim May Be At Stake In “Complete Response” Letter

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

FDA could have concerns about the reported data from the ARISTOTLE trial, either from the bleeding comparisons or the dosing in the warfarin control arm. Missing data is another possible issue, as in the recent “complete response” letter for J&J/Bayer’s Xarelto.

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