ARCA biopharma, Inc.
ARCA Receives FDA Fast Track Designation for GencaroTM Development in Genotype-Defined Heart Failure Population
Published in Cardiovascular Business Week, December 8th, 2009
ARCA biopharma, Inc. (Nasdaq:ABIO) announced that the U.S. Food and Drug Administration (FDA) has designated as a Fast Track development program the investigation of GencaroTM, the Company's investigational, pharmacologically unique beta-blocker and mild vasodilator, for the reduction of cardiovascular mortality and cardiovascular hospitalizations in a genotype-defined heart failure population. The Company intends to submit a study protocol for review under the FDA's Special Protocol Assessment (SPA) process for the design of a clinical trial to assess the safety and efficacy of Gencaro in approximately 3,000 patients with chronic heart failure who have the genotype that appears to respond...
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