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No New Trials, Omapro "Complete Response" Says, But Diagnostic Is Desired

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Australian-headquartered ChemGenex received a "complete response" letter from FDA for its new drug application for Omapro (omacetaxine mepesuccinate) for chronic myeloid leukemia, and the company is breathing a sigh of relief that it will not have to conduct additional trials or enroll additional patients, the company said April 12

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