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No Additional Omapro Trials Needed, U.S. FDA Tells Australian ChemGenex In Complete Response Letter

This article was originally published in PharmAsia News

Executive Summary

PERTH, Australia - Australian-headquartered ChemGenex received a complete response letter from U.S. 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, ChemGenex said April 12
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