Delcath Says FDA Designated NDA for Standard Review; Expects to Get 74 Day Letter by the End of October

Delcath Systems, Inc. (NASDAQ: DCTH) announcedtoday that the U.S. Food and Drug Administration (FDA) has accepted theCompany's New Drug Application (NDA) for its proprietary chemosaturationsystem with melphalan hydrochloride for injection.  The FDA has designated theNDA for standard review. Delcath expects to be notified of its PDUFA date inthe FDA's 74-Day letter, which the Company expects to receive by the end ofOctober. Under the Prescription Drug User Fee Act (PDUFA), the FDA has thegoal of completing its review of applications designated for standard reviewwithin 10 months of the NDA submission, which was submitted on August 15,2012. The Company is seeking approval for its proprietary chemosaturationsystem with melphalan hydrochloride as a treatment for patients withunresectable metastatic melanoma in the liver.