EMERYVILLE, Calif., Dec. 3 /PRNewswire-FirstCall/ -- Bionovo, Inc. (Nasdaq: BNVI) today 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 to best implement the Agency's Guidance for Industry for Botanical Drug Products. Bionovo will be moving with all possible diligence to reach agreement on these areas with the FDA. We will start manufacturing the clinical material using the commercial process immediately. During these discussions no concerns were expressed about either the safety nor the efficacy of Menerba," said Dr. Isaac Cohen, Bionovo's Chairman and CEO.
Bionovo completed a multicenter Phase 2, double-blind, placebo-controlled
randomized clinical trial evaluating Menerba for the treatment of hot flashes
in 217 healthy post-menopausal women enrolled at 6 clinical sites in the U.S.
The principal investigator of the trial was Dr. Deborah Grady from the
|SOURCE Bionovo, Inc.|
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