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Technical Difficulties Prevented Priority Review Of GSK Melanoma Drugs

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

GlaxoSmithKline withdrew priority review requests for its high-profile melanoma drugs Mekinist and Tafinlar as extensive problems with both the quality of the NDA data and the statistical analysis software in the electronic submissions emerged. Statistical reviewers called out sponsor for inadequate response to problems, wasting time.


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