Navigation Links
Delcath Systems Provides Update on Corporate Developments
Date:3/12/2010

g our strategies to gain regulatory approval to market the Delcath PHP System both in the U.S. and in Europe, expand the potential benefits of the Delcath PHP System to patients worldwide and build increasing returns to our shareholders," said Eamonn P. Hobbs, President & CEO.  "Overall, we have made significant progress towards our goals and expect to begin the New Drug Application (NDA) process for FDA approval as soon as practically possible."

"The next operational milestone for our company is the April completion of data analysis from our Phase III trial," said Mr. Hobbs.  "The trial's data analysis involves the initial review by the principal clinical investigators at each enrolling center, an additional review by the Company's retained Clinical Research Organization, and a final review of medical images for verification of results conducted by an independent core lab before final statistical results are compiled by an independent biostatistical group.  We remain highly confident that the trial's data will meet the trial's primary endpoint, and our confidence was recently further buoyed by the FDA's acknowledgement of an expanded access program," added Mr. Hobbs. "Operationally, we are on track to have an inspectable Quality System at our Queensbury manufacturing facility by April, which is a key step in the positioning of the Company for commercialization."

"Our only recent adjustment to our plan has been a revision in our filing
'/>"/>

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

Page: 1 2 3 4 5 6 7 8 9 10 11 12

Related medicine technology :

1. Delcath Expands Phase III Trial for Metastatic Melanoma to Include University of Maryland Medical Center
2. Delcath Updates Phase III Patient Enrollment as Pivotal Trial Accelerates, Durable Tumor Responses In Phase II Study Also Cited
3. Delcath Expands Phase III Trial for Metastatic Melanoma to Include St. Lukes Cancer Center
4. Delcath Adds Dr. Pamela R. Contag to Its Board of Directors
5. Delcath Continues Expansion of Clinical Trial Centers Offering PHP(TM)
6. Enrollment in Delcaths Pivotal Phase III Metastatic Melanoma Clinical Trial Achieves Seventy-Five Percent Accrual
7. Data Safety Monitoring Board Unanimously Recommends Continuation of Delcaths Phase III Clinical Trial
8. Delcath Systems, Inc. Appoints Dr. Krishna Kandarpa its Executive Vice President R&D and Chief Medical Officer
9. Delcath Systems, Inc. Completes Phase III Study Enrollment
10. Delcath Systems Begins Data Analysis of Phase III Trial
11. Delcath Systems, Inc. to Present at the 12th Annual Needham Growth Stock Conference
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/19/2014)... 2014 According to market ... Mobile, Industrial, & Laboratory), Industry (Food, Pharmaceutical, Biotechnology, ... Rotary) & Geography - Global Trends & Forecast ... the lyophilization market on the basis of various ... of the market size of each of these ...
(Date:9/19/2014)... 19, 2014  Lpath, Inc. (NASDAQ: ... therapeutics, announced today that it has entered into ... common stock and 3,605,042 unregistered warrants in a ... one registered share of common stock and one ... common stock will be $3.475.  The warrants have ...
(Date:9/19/2014)... LONDON , September 19, 2014 ... hat Pharma IQ den äußerst erfolgreichen Serialisierungs-Countdown-Kalender aktualisiert, ... abdeckt. Die interaktive PDF, verfügbar unter pharmaserialisation.com ... an dem sie jeweils in Kraft treten. ... der Serialisierung nicht länger um das "ob", sondern ...
Breaking Medicine Technology:Lyophilization Market Worth $5,121.5 Million by 2019 2Lyophilization Market Worth $5,121.5 Million by 2019 3Lpath, Inc. Announces $12.5 Million Registered Direct Offering 2Lpath, Inc. Announces $12.5 Million Registered Direct Offering 3Pharma IQ stellt weltweite Serialisierungsfristen in seinen Countdown-Kalender 2014 - 2018 2
(Date:9/19/2014)... 2014 Unbound , an international humanitarian ... regions of the Philippines being affected by both a tropical ... families evacuated to the nearest public schools while others moved ... and gusty winds to portions of the northern Philippines. ... homes filled with more than 10 feet of water. ...
(Date:9/19/2014)... Phoenix, AZ (PRWEB) September 19, 2014 Hastings ... over 30 years in the industry, announces a record number ... firm handles a wide variety of serious injury cases as ... cases along with dog bite related accident cases and others. ... Hastings and Hastings has stood the test of time when ...
(Date:9/19/2014)... U.S. military troops deployed to sunny climates may have ... new study. Many returning troops reported getting ... military personnel developed blisters on their skin or noticed ... their moles since being deployed overseas. All of ... the study authors noted. "The past decade of ...
(Date:9/19/2014)... Alan Mozes HealthDay Reporter ... Cancer patients burdened by stress and family conflicts before ... their operation, a new study suggests. Investigators found ... have a nearly three times greater risk for complications ... of life. "We,ve long known that patient quality ...
(Date:9/19/2014)... Pittsburgh, PA (PRWEB) September 19, 2014 ... I fear getting wrinkles due to stretching the skin ... from Anniston, Ala. "This inspired me to design a ... HANDS-FREE EYE CONTACT LENS SYSTEM provides a quicker, easier, ... eliminates the need to perform this task manually, saves ...
Breaking Medicine News(10 mins):Health News:Double Threat in Philippines Displaces Thousands of Unbound Families 2Health News:Hastings And Hastings Announces a Record Number of Visitors to Its New Phoenix Personal Injury Website 2Health News:Some U.S. Troops May Face Greater Skin Cancer Risk 2Health News:Family Squabbles Can Derail Recovery From Cancer Surgery 2Health News:Family Squabbles Can Derail Recovery From Cancer Surgery 3
... , WASHINGTON, June 23 Today the 400,000-strong ... Manufacturers of America (PhRMA) for its commitment to ... 50 percent for seniors who fall into the ... Phillips, RetireSafe President, called the commitment, "a huge ...
... disorders are frequently seen as psychological or societal,diseases, but ... study,shows that the levels of a brain protein differ ... and occasionally fatal eating disorder most commonly,affecting women. Scientists ... some studies suggest a link to low levels of ...
... Derma Sciences, Inc. (OTC Bulletin Board: ... today that it has begun shipping BIOGUARD(TM) Barrier Dressings ... has been awarded reimbursement codes for the dressings, allowing ... will offer surgeons, wound care clinicians, infection control experts ...
... Pa., June 23 The Department of Health has received ... Housing and Urban Development, or HUD, to implement a new ... in Erie and Philadelphia. , , "The Healthy ... housing related hazards for children such as mold, radon, and ...
... ... Vivacare has included medication rebate coupons and medication brochures as ... the needs of physicians and patients, and improve medication adherence. 69% ... help them to fill their medication at the pharmacy. 86% of ...
... /PRNewswire-Asia/ -- Wan (Corporate Services) Ltd., the,sole agent of Perrier in Hong ... Perrier. , Perrier Clarifies ... We strongly believe the Consumer Council Findings is not correct. , ... Nitrite in Perrier is,not correct. , Nitrite content ...
Cached Medicine News:Health News:Derma Sciences Announces First Commercial Sales of BIOGUARD(TM) Barrier Dressings 2Health News:Derma Sciences Announces First Commercial Sales of BIOGUARD(TM) Barrier Dressings 3Health News:Derma Sciences Announces First Commercial Sales of BIOGUARD(TM) Barrier Dressings 4Health News:Pennsylvania Department of Health Receives Recovery Funds for New Healthy Homes Program 2Health News:Vivacare Patient Education Service Includes Medication Rebates and Brochures to Improve Medication Adherence 2Health News:Vivacare Patient Education Service Includes Medication Rebates and Brochures to Improve Medication Adherence 3Health News:Perrier Clarifies the NITRITE Level in Consumer Council Findings 2
Hard protective shields for post-operative or post-injury use. Universal, or Left/Right specific. Packaged 12 per box....
Hard protective shields for post-operative or post-injury use. Universal, or Left/Right specific. Packaged 12 per box....
... provide a broad selection of ... a wide variety of ophthalmic ... is packaged sterile, complete with ... switch in the "off " ...
... provide a broad selection of ... a wide variety of ophthalmic ... is packaged sterile, complete with ... switch in the "off " ...
Medicine Products: