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FDA Schedules Delcath Pre-New Drug Application Meeting Date
Date:10/26/2011

NEW YORK, Oct. 26, 2011 /PRNewswire/ -- Delcath Systems, Inc. (NASDAQ: DCTH) announced today that the U.S. Food and Drug Administration (FDA) has responded to the Company's request made in September for a pre-New Drug Application (NDA) meeting and has scheduled a date in mid-January 2012.  Delcath plans to submit the NDA for its proprietary chemosaturation system, used in the treatment of patients with metastatic melanoma in the liver through the percutaneous intra-arterial administration of melphalan hydrochloride, after the Company has incorporated FDA's feedback from that meeting into the NDA submission.  

Delcath currently expects to update investors on its U.S. and international regulatory progress, EU commercialization preparations and other corporate progress in the third quarter 2011 during a conference call on Monday, November 7, 2011 at 4:30 PM EST.  The Company will issue details of the call later this week.

About Delcath SystemsDelcath Systems, Inc. is a development stage specialty pharmaceutical and medical device company focused on oncology. Delcath's proprietary system for chemosaturation is designed to administer high dose chemotherapy and other therapeutic agents to diseased organs or regions of the body, while controlling the systemic exposure of those agents. The Company's initial focus is on the treatment of primary and metastatic liver cancers. In 2010, Delcath concluded a Phase 3 metastatic melanoma study, and the Company recently completed a multi-arm Phase 2 trial to treat other liver cancers. The Company obtained authorization to affix a CE Mark for the Delcath Hepatic CHEMOSAT delivery system in April 2011. The Company has not yet received FDA approval for commercial sale of its system in the United States. For more information, please visit the Company's website at http://www.delcath.com/'/>"/>

SOURCE Delcath Systems, Inc.
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