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24 Sep 2010

FDA accepts CMC plan for lead Bionovo drug

The FDA has accepted Bionovo's chemistry, manufacturing and controls (CMC) plan for its lead drug candidate, Menerba.

The FDA has accepted Bionovo's chemistry, manufacturing and controls (CMC) plan for its lead drug candidate, Menerba. With the FDA's approval of the company's CMC plan, Bionovo is now in final discussions with the agency to complete the design of the Phase III pivotal trials in the U.S.

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