Navigation Links
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/.

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 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, if any, in the United States, the time required to build inventory and establish commercial operations in Europe, adoption, use and resulting sales, if any, for the Hepatic CHEMOSAT delivery system in the EEA, 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 foreign regulatory agencies, our ability to obtain reimbursement for the CHEMOSAT system, our ability to successfully enter into distribution and strategic partnership agreements in foreign markets and the corresponding revenue associated with such foreign markets, uncertainties relating to the results of research and development projects and future clinical trials, 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.Contact Information:Investor Contact:

Media Contact:Doug Sherk/Gregory Gin

Janine McCargoEVC Group

EVC Group415-568-4887/646-445-4801

646-688-0425
'/>"/>

SOURCE Delcath Systems, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. WuXi PharmaTech Schedules Third-Quarter 2011 Earnings Release
2. Thoratec Schedules Third Quarter Conference Call, Webcast
3. 3SBio Inc. Schedules Unaudited Third Quarter 2011 Results
4. Varian Medical Systems Schedules Fiscal Year End Review for Investors in New York
5. Volcano Corporation Schedules Third Quarter Conference Call, Webcast
6. MSA Schedules Third Quarter Earnings Webcast
7. Cepheid Schedules 2011 Third Quarter Financial Results Announcement and Webcast
8. Telik Announces Publication in the Journal Cancer of a Phase 2 Randomized Multicenter Study of Two Extended Dosing Schedules of Oral Ezatiostat in Low to Intermediate-1 Risk Myelodysplastic Syndrome
9. Varian Medical Systems Schedules Fourth Quarter FY2011 News Release and Conference Call
10. China Nepstar Chain Drugstore Schedules Annual General Meeting of Shareholders for October 25, 2011
11. Misonix Schedules Fourth Quarter and Year-End Fiscal 2011 Financial Results Conference Call; September 20, 2011 at 4:30 p.m. Eastern
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/23/2017)... 23. Januar 2017  ResMed (NYSE: RMD ... 3B Medical ( Winter Haven, Florida ) ... über die Beilegung aller globalen Rechtsstreitigkeiten zwischen den Parteien ... ihrer bestehenden Produkte im Tausch gegen Lizenzgebühren an ... 3B leisten, um das in Florida ...
(Date:1/23/2017)... Jan. 23, 2017 Just two weeks remain until legal experts ... gather in Central London to discuss the flow ... in the market, Parallel Trade 2017 . In the ... of attendees which is available to read in the event download ... Some of ...
(Date:1/21/2017)... According to a new market research report "Life Science ... Component (Software, Service), Delivery (On premise, Cloud), End user (Pharmaceutical, Biotechnology, ... market is expected to reach USD 24.73 Billion by 2021 from ... the forecast period. Continue Reading ... ...
Breaking Medicine Technology:
(Date:1/23/2017)... Portland, Oregon (PRWEB) , ... January 23, 2017 ... ... systems, announced today it has earned organic certification under the USDA National Organic ... the USDA Organic Certification process, we have established organic production and handling systems ...
(Date:1/23/2017)... ... ... “The Inn at the Mill”: a story of love and redemption, hope and uncertainty ... and content. , “The Inn at the Mill” is the creation of published author, ... and is now living in Berks County on Crow Hill. The inn, the ...
(Date:1/23/2017)... Georgia (PRWEB) , ... January 23, 2017 , ... Valentine’s Day is a time when ... their loved ones. For those who may be looking for the ideal present, Atlanta-based ... certificate and get an additional $25 free. Or, spend $200 and get $50 free. ...
(Date:1/21/2017)... FL (PRWEB) , ... January 21, 2017 , ... Caronlab ... recently attended the January ECRM Trade Show in Hilton Head, SC, where it benefited ... reputation for the quality of its beauty and wellness products. At this trade show, ...
(Date:1/21/2017)... , ... January 21, 2017 , ... ... Alumni Relations, Dianne Travis-Teague, the electrifying line-up of events for its annual meeting ... family, friends, and community. “Coming Home 2017” will be held on Friday ...
Breaking Medicine News(10 mins):