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ARTICLE | Company News

Delcath falls after FDA reviewers question Melblez Kit safety

May 1, 2013 12:39 AM UTC

Delcath Systems Inc. (NASDAQ:DCTH) fell $0.56 (40%) to $0.83 on Tuesday after FDA reviewers said the company's Melblez Kit chemosaturation system, which delivers melphalan to treat unresectable ocular melanoma that is metastatic to the liver, has a "high treatment related mortality rate that in the best-case scenario would be replicated in the post-marketing setting." The reviewers said Delcath must also evaluate in a clinical trial the version of the kit for which it is seeking approval "to have confidence in the safety profile of that iteration of the Melblez Kit." Delcath is seeking approval of a version of the system that contains a different generation of filter in the delivery device that was not tested in trials supporting the NDA. ...