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Menopause
Bionovo Announces Development Plans for Menopausal Hot Flash Drug Candidate, Menerba (MF101), Following FDA Meetings
December 15th, 2008
Bionovo, Inc. (NASDAQ:BNVI) announced that the FDA has reviewed the company's manufacturing and control process descriptions (CMC), and has provided guidance on how Bionovo can move forward with the development of Menerba (formerly named MF101) for menopausal hot flashes. "We have concluded three CMC discussions with the FDA, and are moving to address the Agency's recommendations for further development of Menerba. The recommendations with respect to the analytical characterization were made by the Pre-Marketing division of the Agency, in order to ensure continuous drug consistency. There are some areas of the drug development process requiring further discussion on how...
Source: Clinical Trials Week (2008-12-15)
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