Navigation Links
Delcath to Update Investors on FDA Meeting
Date:4/5/2011

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

EVC Group646-455-4801/415-896-6818

646-528-4034
'/>"/>

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

Related medicine technology :

1. Delcath Expands Board of Directors With Appointment of Gabriel Leung
2. Delcath to Present at Upcoming Investor Conferences
3. Delcath Systems Receives Refusal to File Letter From FDA
4. Delcath Achieves ISO 13485 Certification
5. Delcath Completes New Drug Application Submission to the FDA for the Chemosaturation Delivery System
6. Delcath Systems Announces Third Quarter Progress Report Conference Call
7. Delcath Strengthens Research and Development Team with Key Appointments
8. Delcath Signs Agreement With Synerx and Mylans Bioniche Teoranta for Melphalan Supply
9. Delcath to Present at the William Blair Emerging Growth Stock Conference
10. Delcath to Present at the JMP Securities Healthcare Conference
11. Delcath Systems Announces Completion of Common Stock Offering
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... 23, 2016  Guerbet announced today that it has ... Horizon Award . One of 12 suppliers ... for its support of Premier members through exceptional local ... and commitment to lower costs. ... of our outstanding customer service from Premier," says ...
(Date:6/23/2016)... -- The Biotechnology industry might still be ... opportunities to investors. Stock-Callers.com assesses the recent performances of ... XON ), Vertex Pharmaceuticals Inc. (NASDAQ: ... ), and Regeneron Pharmaceuticals Inc. (NASDAQ: REGN ... complimentary trade alerts at: http://stock-callers.com/registration ...
(Date:6/23/2016)... Research and Markets has announced the addition ... New Global Agenda " report to their offering. ... Europe - the 2016 edition is a ... identifies the driving factors coming into play which will influence ... and in the future. It provides a wealth of knowledge ...
Breaking Medicine Technology:
(Date:6/24/2016)... ... , ... A recent article published June 14 on E Online ... on to state that individuals are now more comfortable seeking to undergo not only ... calf and cheek reduction. The Los Angeles area medical group, Beverly Hills Physicians (BHP) ...
(Date:6/24/2016)... Fla. (PRWEB) , ... June 24, 2016 , ... Global ... Trend magazine’s 2016 Legal Elite. The attorneys chosen by their peers for this recognition ... Florida. , Seven Greenberg Traurig Shareholders received special honors as members of this year’s ...
(Date:6/24/2016)... ... June 24, 2016 , ... EB Medicine presented ... in Emergency Medicine conference in Ponte Vedra Beach, FL. The awards honor the ... Emergency Medicine Practice and Pediatric Emergency Medicine Practice. , “With this award, ...
(Date:6/24/2016)... (PRWEB) , ... June 24, 2016 , ... Venture ... Golf Classic Tournament held on June 20th at the Woodmont Country Club at ... Luke’s Wings, an organization dedicated to helping service members that have been wounded in ...
(Date:6/24/2016)... ... June 24, 2016 , ... Southern Illinois ... are co-chairs for the Illinois State Dental Society (ISDS) Foundation’s Mission of Mercy ... Gateway Convention Center in Collinsville. , They expect to treat approximately ...
Breaking Medicine News(10 mins):