NEW YORK, Feb. 22, 2011 /PRNewswire/ -- Delcath Systems, Inc. (Nasdaq:DCTH - News) announced today that the Company has received a “refusal to file” letter from the U.S. Food & Drug Administration (FDA) for the New Drug Application (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. Delcath expects to submit a formal meeting request to the FDA this week and intends to meet with the FDA at the earliest opportunity to discuss the issues raised and to confirm our understanding of the remedies required for the filing to be accepted. Based on management’s current understanding of the information in the FDA’s letter, the Company intends to resubmit the NDA by September 30, 2011.
