FDA staff questions clinical significance of ChemGenex drug

02/8/2010 | Bloomberg

ChemGenex Pharmaceuticals' Omapro had a "low" response rate among patients with chronic myeloid leukemia who carry the T315I genetic mutation, FDA staff reported. "The company is aware of the questions posed by the FDA, and we are confident in our ability to answer these questions" at a meeting of the FDA's Oncologic Drugs Advisory Committee on Wednesday, ChemGenex said.

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