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In Brief: PreMD Inc.
Monday, August 18 2008 | Comments
What's This?
PreMD Inc. shares fell 62 percent on news that the Food and Drug Administration upheld its decision regarding the not substantially equivalent letter the company received in January in connection with its premarket submission to expand the indication for use of its Prevu point-of-care (POC) skin cholesterol test to aid in the assessment of carotid wall thickness and the presence of carotid plaques in patients without known coronary artery disease, cerebrovascular disease or peripheral artery disease. According to PreMD, the agency maintained its position that that there are fundamental defects in both the study design and data analysis of the submission. As previously reported, the FDA did not believe the primary endpoint of carotid wall intima thickness was a clinically useful way to evaluate skin cholesterol. PreMD--which maintained that it sought and received guidance from the FDA regarding the clinical trial design and data required for an expanded indication for the test--said it would examine its options. The Prevu POC is cleared for use as part of risk assessment for CAD in persons with a history of myocardial infarction and/or in persons suspected of having clinically significant CAD. PreMD shares closed at $0.11, down $0.18 in heavy trading on the American Stock Exchange.
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