Bionovo receives EMA terminating direction concerning advancing Menerba to Wind up 3 clinical trials
Bionovo, Inc. (Nasdaq: BNVI) announced today that it has received fixed control from the European Medicines Power (EMA) in legal code to prepay Menerba, the company’s move treat runner on account of menopausal symptoms, to Shape 3 clinical trials in Europe. The charge defines the clinical and regulatory pathway to a European marketing authorization in the interest of Menerba.
"We are walking on air with the upshot of our Detailed Counsel meetings with the European Medicines Force. We are yearning to snap this control to bring into play and to start our till organize vital studies to Menerba," said Isaac Cohen, O.M.D., Bionovo’s Chairman and Chief Numero uno Dick.
"There are 37 million menopausal women in Europe and, with a European marketing authorization, we think the European hawk insist to be impressed as a justifiable and useful surrogate to hormone group therapy since the treatment of red-hot flashes," said Mary Tagliaferri, M.D., Bionovo’s President and Chief Medical Constable.
The Convention has also had a get-together with the U.S. Subsistence and Knock out Administering (FDA) on the unfolding of Menerba in the U.S., and looks aid to providing more details when the minutes of the intersection are released.
WELL-SPRING Bionovo, Inc.
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