Tivozanib “Complete Response” Shows Increased Communications Can’t Always Save An NDA

This article was originally published in The Pink Sheet Daily

11 Jun 2013
News

Sue Sutter @PinkSheetSutter sue.sutter@informa.com

Executive Summary

Aveo got extensive advice from FDA, but bad data and its decision not to conduct an additional trial led to a rejection for its kidney cancer application.

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Drug Approval Standards

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Tivozanib “Complete Response” Shows Increased Communications Can’t Always Save An NDA

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