FDA responds to Delcath's request for pre-NDA meeting

FDA responds to Delcath's request for pre-NDA meeting

News and Articles
Oct 27 2011

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.

Source:

Delcath Systems, Inc.

Source: www.news-medical.net

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