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Aceon User Fee Deadline Extended To Allow For Clinical Trial Site Audits

This article was originally published in The Pink Sheet Daily

Executive Summary

Audits of European clinical trial sites have shown “more audit observations than the FDA was comfortable with,” CV Therapeutics says. The 90-day extension will allow for further audits of the EUROPA trial sites. CVT may add a product for its cardiovascular sales team to promote alongside Aceon and Ranexa.
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