The FDA's review of MELAFind released Tuesday was staggeringly negative. The agency's reviewers concluded that the clinical studies MELA submitted for MELAFind's approval were inadequate and showed the device to be less accurate than trained dermatologists in detecting potentially deadly melanomas.
The only reason for today's panel, in fact, is because Mela insisted it be scheduled. FDA, in March 2010, had already issued Mela a "not approvable" letter rejecting MELAFind. Mela continues to defend MELAFind and said Tuesday that the FDA's criticisms were "completely without context." The company will try to persuade the FDA panel members today that MELAFind is approvable.Thursday's advisory panel will to review data presentations from MELA and FDA before voting on whether to recommend MELAFind for approval. MELAFind is a computer-enhanced imaging device that takes high-tech pictures of suspect moles and lesions to assist doctors in the early detection of melanoma, the deadliest form of skin cancer. Mela shares closed Wednesday at $2.53. The stock has lost 60% of its value in the past two trading days. --Written by Adam Feuerstein in Boston.
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