NEW YORK, April 5, 2011 /PRNewswire/ -- Delcath Systems, Inc. (NASDAQ: DCTH), a development stage, specialty pharmaceutical and medical device company focused on oncology, announced today that the Company will meet this week with the U.S. Food & Drug Administration (FDA) to discuss the Refusal to File letter that it received from the FDA on February 18, 2011 and the resubmission of its New Drug Application (NDA) for its proprietary chemosaturation system. Delcath management will host a conference call to provide an update to investors on the status of the resubmission of its NDA on April 11, 2011 at 4:30 p.m. Eastern Time.
Conference Call InformationThe dial-in number for the conference call is 866-225-8754 for domestic participants and 480-629-9692 for international participants. An audio replay of the call will be available for seven days following the call, and can be accessed by dialing 800-406-7325 for domestic callers and 303-590-3030 for international callers, both using passcode 4431725#. The call will also be available on the Internet live and for 7 days thereafter at www.delcath.com.
About Delcath SystemsDelcath Systems, Inc. is a 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 III metastatic melanoma study, and the Company recently completed a multi–arm Phase II trial to treat other liver cancers. The Company has not yet received FDA or any foreign regulatory approval for commercial sale of its system. For more information, please visit the Company's website at www.delcath.com.
The Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward–looking statements made by the Company or on its behalf. This news release contains forward–looking statements, which are subject to certain risks and uncertainties that can cause actual results to differ materially from those described. Factors that may cause such differences include, but are not limited to, uncertainties relating to the acceptability of the Phase III clinical trial data by the FDA, our ability to address the issues raised in the Refusal to File letter received from the FDA and the timing of our re-submission of our NDA, re-submission and acceptance of the Company's NDA by the FDA, approval of the Company's NDA for the treatment of metastatic melanoma to the liver, adoption, use and resulting sales in the United States, acceptance of the Company's CE Mark Technical File by its Notified Body, receipt of CE Mark approval, adoption, use and resulting sales in the EU, if any, our ability to successfully commercialize the chemosaturation system and the potential of the chemosaturation system as a treatment for patients with terminal metastatic disease in the liver, approval of the current or future chemosaturation system for other indications, actions by the FDA or other regulatory agencies, our ability to successfully enter into distribution and strategic partnership agreements in foreign markets and the corresponding revenue associated with such foreign markets, and uncertainties regarding our ability to obtain financial and other resources for any research, development and commercialization activities. These factors, and others, are discussed from time to time in our filings with the Securities and Exchange Commission. You should not place undue reliance on these forward–looking statements, which speak only as of the date they are made. We undertake no obligation to publicly update or revise these forward–looking statements to reflect events or circumstances after the date they are made.Investor Contact:
Media Contact:Gregory Gin/Doug Sherk
Janine McCargoEVC Group
|SOURCE Delcath Systems, Inc.|
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