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FDA panel votes down Delcath's Melblez Kit

May 3, 2013 12:23 AM UTC

FDA's Oncologic Drugs Advisory Committee voted 16-0 that the benefit-risk profile of Melblez Kit chemosaturation system from Delcath Systems Inc. (NASDAQ:DCTH) does not support approval to treat unresectable ocular melanoma that is metastatic to the liver. Trading in Delcath was halted on Thursday. The stock fell $0.56 (40%) to $0.83 on Tuesday after FDA reviewers said Melblez Kit has a high treatment-related mortality rate (see BioCentury Extra, April 30). ...