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