Navigation Links
Delcath Systems Receives Refusal to File Letter From FDA
Date:2/22/2011

latory 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 questions raised in the FDA's refusal to file letter and re-submit an NDA by the end of our third quarter, 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, 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 pu
'/>"/>

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

Page: 1 2 3 4

Related medicine technology :

1. Delcath Achieves ISO 13485 Certification
2. Delcath Completes New Drug Application Submission to the FDA for the Chemosaturation Delivery System
3. Delcath Systems Announces Third Quarter Progress Report Conference Call
4. Delcath Strengthens Research and Development Team with Key Appointments
5. Delcath Signs Agreement With Synerx and Mylans Bioniche Teoranta for Melphalan Supply
6. Delcath to Present at the William Blair Emerging Growth Stock Conference
7. Delcath to Present at the JMP Securities Healthcare Conference
8. Delcath Systems Announces Completion of Common Stock Offering
9. Delcath to Present at the 30th Annual Canaccord Global Growth Conference
10. Delcath to Present at the 2010 Wedbush Securities Life Sciences Best Ideas Management Access Conference
11. Delcath Systems Announces Second Quarter Progress Report Conference Call
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/30/2015)... und KOPENHAGEN, Dänemark, 30. Juni 2015 /PRNewswire/ ... Weltmarktführer der klinischen und kommerziellen Produktion von ... heute bekannt, dass das Unternehmen im Rahmen ... der nordamerikanischen Produktionsanlage in Bothell, ... Einweg-Anlage Bioreactor 6Pack™ komplettiert hat. Die Konfiguration ...
(Date:6/30/2015)... 30, 2015  EnteroMedics Inc. (NASDAQ: ETRM ), ... technology to treat obesity, metabolic diseases, and other gastrointestinal ... offering  of 40,229,886 units. Each unit consists of one ... warrant to purchase one share of common stock, and ... share of common stock, at a purchase price of ...
(Date:6/30/2015)... 2015  Egalet Corporation (Nasdaq: EGLT ... company focused on developing, manufacturing and marketing ... from a Category 3 human abuse liability ... oral oxycodone product candidate in late-stage clinical ... enough to require daily, around-the-clock opioid treatment ...
Breaking Medicine Technology:CMC Biologics baut GMP-Produktionskapazität in den USA aus 2CMC Biologics baut GMP-Produktionskapazität in den USA aus 3EnteroMedics Inc. Announces Pricing of $35.0 Million Public Offering of Common Stock and Warrants 2EnteroMedics Inc. Announces Pricing of $35.0 Million Public Offering of Common Stock and Warrants 3Egalet Announces Top-Line Results from Oral Human Abuse Liability Study of Egalet-002 2Egalet Announces Top-Line Results from Oral Human Abuse Liability Study of Egalet-002 3Egalet Announces Top-Line Results from Oral Human Abuse Liability Study of Egalet-002 4Egalet Announces Top-Line Results from Oral Human Abuse Liability Study of Egalet-002 5
(Date:6/30/2015)... ... June 30, 2015 , ... After many requests from international ... here, http://www.express-glasses.com is proud to announce its collaboration with DHL for ... with DHL Express when calling or visiting the express glasses website. express glasses ...
(Date:6/30/2015)... , ... June 30, 2015 , ... ... currently pending in a federal multidistrict litigation now underway in the U.S. District ... next monthly Status Conference. According to the Court’s calendar, that conference has now ...
(Date:6/30/2015)... (PRWEB) , ... June 30, 2015 , ... Rocky Mountain ... has restructured its management team and added a new CEO, Mr. Darold Francis. The ... leading selection of premium essential oils that customers have come to know and respect ...
(Date:6/30/2015)... ... June 30, 2015 , ... Allied Anesthesia physicians are ... division volunteered to help provide free outpatient procedures to some of Orange County’s ... Jude Medical Center. , The event was coordinated by AccessOC, which was ...
(Date:6/30/2015)... ... 30, 2015 , ... MJH Associates today welcomed ... Research & Analytics , a consultative healthcare market research practice that is part ... HRA offers quantitative and qualitative, custom and multi-client primary market research services to ...
Breaking Medicine News(10 mins):Health News:Eyeglasses Online - Express Glasses Announcing New International Shipping Using DHL 2Health News:Progress of Federal Xarelto Lawsuits Pending in Multidistrict Litigation to Be Discussed During July 9th Status Conference 2Health News:Progress of Federal Xarelto Lawsuits Pending in Multidistrict Litigation to Be Discussed During July 9th Status Conference 3Health News:Rocky Mountain Oils Adds New CEO, Announces Relocation of Operations to Orem, Utah 2Health News:Allied Anesthesia Physicians Volunteer to Help Orange County’s Uninsured During Annual Super Surgery Saturday 2Health News:Allied Anesthesia Physicians Volunteer to Help Orange County’s Uninsured During Annual Super Surgery Saturday 3Health News:HRA Healthcare Research & Analytics Welcomes 'Creative Problem Solver' as New Executive Vice President 2Health News:HRA Healthcare Research & Analytics Welcomes 'Creative Problem Solver' as New Executive Vice President 3
... , , SOUTH SAN ... PARD ), a biopharmaceutical company focused on innovative oncology ... executive officer, is scheduled to provide a corporate overview, including ... lead product candidate, picoplatin, at two upcoming investor conferences: , ...
... day cut risk in half in study of Finnish men ... associated with moderate- to high-intensity exercise appears to reduce the ... Finnish study included 2,560 men, aged 42 to 61, whose ... the men had a history of cancer, according to the ...
... CDC recommendations loom, new study confirms this group at great ... officials meet Wednesday to decide who should get priority for ... the virus poses to pregnant women should vault that group ... panel convened by the U.S. Centers for Disease Control and ...
... DARIEN, Conn., July 29 Now served in over 4000 schools across ... is expanding its availability into the retail sector. In addition to ... retailers Tops, D,Agostinos, Big Y, Kings and select Whole Foods ... keeps growing with Wegmans, Price Chopper and Kroger,s Eastern divisions all putting ...
... , , , ... EDI Health Group, Inc., (EHG), a provider of enhanced connectivity, ... in the dental industry, today announced significant additions to its ... during which the company implemented its industry-leading EDI (electronic data ...
... , , JACKSONVILLE, Fla., ... of Representatives for passing a bill (H.R. 3155) that will ... but endorsed a Senate bill (S. 801) that would provide ... caregivers who are in dire need of these services. H.R. ...
Cached Medicine News:Health News:Poniard Pharmaceuticals to Present at Two Upcoming Investor Conferences in August 2Health News:Prioritize Pregnant Women to Get Swine Flu Shot, Experts Say 2Health News:Prioritize Pregnant Women to Get Swine Flu Shot, Experts Say 3Health News:Prioritize Pregnant Women to Get Swine Flu Shot, Experts Say 4Health News:People Across the Country are Making The Switch! 2Health News:EDI Health Group Continues to Drive Growth of EDI Processing Services in the Dental Healthcare Industry Through Addition of 25 New Connections in the First Half of 2009 2Health News:EDI Health Group Continues to Drive Growth of EDI Processing Services in the Dental Healthcare Industry Through Addition of 25 New Connections in the First Half of 2009 3Health News:EDI Health Group Continues to Drive Growth of EDI Processing Services in the Dental Healthcare Industry Through Addition of 25 New Connections in the First Half of 2009 4Health News:Wounded Warrior Project (WWP) Pushes for Senate Bill to Assist Family Caregivers of the Most Severely Injured Veterans 2
... A surgically implanted bone growth stimulator ... EBI OsteoGen surgically implanted bone growth stimulator ... of nonunions when surgery is already planned ... concern. Because the OsteoGen is totally surgically ...
... area contact between grant material and fracture ... long bones., ,Grid-Like Format of Mesh Cathode ... Bone , ,The innovative Mesh Cathode of ... area and a scaffolding effect designed to ...
... Flexible Cystoscope System using EndoSheath Technology ... for urologists in both their hospitals ... CST-2000 flexible cystoscope with the sterile, ... cystoscopy procedures, while minimizing the costs ...
... The PK Plasma-CISE™ (wire electrodes) ... single use devices that produce ... minimal thermal spread and Vapor ... superior hemostasis. The devices provide ...
Medicine Products: