Point Biomedical Corporation
Point Biomedical Corporation's Cardiosphere NDA accepted for review by U.S. FDA
Published in Cardiovascular Device Liability Week, April 2nd, 2006
Under Prescription Drug User Fee Act (PDUFA) III, the FDA's goal is to review and act on the NDA by late October of 2006.
Cardiosphere is a myocardial perfusion agent used with ultrasound imaging. Point is seeking approval to market Cardiosphere for the detection and localization of obstructive coronary artery disease.
Point CEO Dr. Jerry Griffin said, "We believe that Cardiosphere may offer important advantages to patients, physicians and payers." If approved for...
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