Earlier this month, Bionovo (BNVI), a development-stage pharmaceutical company, announced a plan of action for its lead product candidate, Menerba, an oral, botanical, drug candidate for the treatment of menopausal hot flashes. In the press release, the company clearly communicated its goal with regards to Menerba's development timeline (click to enlarge images):
This new timeline is a stark contrast to what management previously thought was achievable. Throughout 2009, management believed that they could begin enrolling patients as early as the first quarter of 2010. What exactly was the hold up?
Throughout most of 2010, Bionovo's management had met with the FDA on several occasions to finalize Bionovo's chemistry, manufacturing, and controls plan ("CMC"). In September of 2010, the FDA finally accepted the CMC plan. One major issue was that Menerba is a botanical agent, not exactly the typical new chemical entity that the FDA often evaluates. Secondly, Menerba has multiple,
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Shannyn Sossamon Rachael Leigh Cook Elisha Cuthbert Ciara Rachel Hunter
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