Navigation Links
Delcath Announces Completion of Regulatory Notification Process in New Zealand
Date:10/19/2011

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 our ability to commercialize the CHEMOSAT system in New Zealand including adoption, use and resulting sales, if any, regulatory approval of the CHEMOSAT system in Australia and other countries in the Pacific region, 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, 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, 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 a
'/>"/>

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

0

GOOD

Page: 1 2 3

Related medicine technology :

1. Delcath Announces Updated Efficacy Results From Phase 3 Trial of Chemosaturation for Melanoma Metastases in the Liver Presented at European Multidisciplinary Cancer Congress
2. Delcath to Present at the JMP Securities Healthcare Conference on September 28, 2011
3. Delcath Systems, Inc. Hosts Symposium on Chemosaturation at CIRSE Annual Meeting
4. Delcath Announces Top-Line Results From Metastatic Colorectal Cohort in Phase II Trial of Chemosaturation System
5. Delcath Announces Encouraging Top-Line Results From Hepatobiliary Cohort in Phase II Trial of Chemosaturation System
6. Delcath to Present at the Wedbush 2011 Life Sciences Conference on August 16, 2011
7. Delcath Systems to Report Second Quarter Progress Update and Conduct Conference Call
8. Delcath Systems, Inc. Announces the Completion of Common Stock Offering
9. Delcath Systems, Inc. Announces the Sale of 5,000,000 Shares of Common Stock
10. Delcath on Preliminary List of Additions to Russell Microcap® Index
11. Delcath to Present at the JMP Securities Research Conference
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/19/2013)... June 19, 2013   Voices Against Brain Cancer ... cure for brain cancer, today announced that it has ... support the clinical investigation of Toca 511 & Toca ... glioma brain cancer (Grade 3 or Grade 4).  Tocagen ... for advanced cancer, with an initial focus on brain ...
(Date:6/19/2013)...   Nektar Therapeutics (Nasdaq: NKTR ) ... (HAL) study for NKTR-181, a first-in-class, opioid analgesic ... This slow rate of entry is designed to reduce the ... to current opioid analgesics. 1 In the study data ... placebo in "drug liking" and "feeling high" scores and had ...
(Date:6/19/2013)... ZIONA, Israel , June 19, ... that results from a phase I study in volunteers, ... advanced Parkinson,s patients, of ND0612, were presented at the ... ND0612 is a proprietary levodopa/carbidopa liquid drug formula under ... patch that would maintain constant levodopa plasma concentrations. ...
Breaking Medicine Technology:Voices Against Brain Cancer Awards Grant to Tocagen to Support Investigation of Toca 511 & Toca FC in Patients with Recurrent Brain Cancer 2Voices Against Brain Cancer Awards Grant to Tocagen to Support Investigation of Toca 511 & Toca FC in Patients with Recurrent Brain Cancer 3Nektar Therapeutics Presents Positive Data from Human Abuse Liability Study for NKTR-181, a First-in-Class Investigational Opioid to Treat Chronic Pain, at 2013 Annual Meeting of The College on Problems of Drug Dependence 2Nektar Therapeutics Presents Positive Data from Human Abuse Liability Study for NKTR-181, a First-in-Class Investigational Opioid to Treat Chronic Pain, at 2013 Annual Meeting of The College on Problems of Drug Dependence 3Nektar Therapeutics Presents Positive Data from Human Abuse Liability Study for NKTR-181, a First-in-Class Investigational Opioid to Treat Chronic Pain, at 2013 Annual Meeting of The College on Problems of Drug Dependence 4Nektar Therapeutics Presents Positive Data from Human Abuse Liability Study for NKTR-181, a First-in-Class Investigational Opioid to Treat Chronic Pain, at 2013 Annual Meeting of The College on Problems of Drug Dependence 5Nektar Therapeutics Presents Positive Data from Human Abuse Liability Study for NKTR-181, a First-in-Class Investigational Opioid to Treat Chronic Pain, at 2013 Annual Meeting of The College on Problems of Drug Dependence 6Nektar Therapeutics Presents Positive Data from Human Abuse Liability Study for NKTR-181, a First-in-Class Investigational Opioid to Treat Chronic Pain, at 2013 Annual Meeting of The College on Problems of Drug Dependence 7Nektar Therapeutics Presents Positive Data from Human Abuse Liability Study for NKTR-181, a First-in-Class Investigational Opioid to Treat Chronic Pain, at 2013 Annual Meeting of The College on Problems of Drug Dependence 8Nektar Therapeutics Presents Positive Data from Human Abuse Liability Study for NKTR-181, a First-in-Class Investigational Opioid to Treat Chronic Pain, at 2013 Annual Meeting of The College on Problems of Drug Dependence 9NeuroDerm Announces Presentation of Data from Studies Evaluating ND0612, an Investigational Levodopa Continuous Administration Drug, in Healthy Volunteers and in Patients with Advanced Parkinson's Disease 2NeuroDerm Announces Presentation of Data from Studies Evaluating ND0612, an Investigational Levodopa Continuous Administration Drug, in Healthy Volunteers and in Patients with Advanced Parkinson's Disease 3NeuroDerm Announces Presentation of Data from Studies Evaluating ND0612, an Investigational Levodopa Continuous Administration Drug, in Healthy Volunteers and in Patients with Advanced Parkinson's Disease 4NeuroDerm Announces Presentation of Data from Studies Evaluating ND0612, an Investigational Levodopa Continuous Administration Drug, in Healthy Volunteers and in Patients with Advanced Parkinson's Disease 5NeuroDerm Announces Presentation of Data from Studies Evaluating ND0612, an Investigational Levodopa Continuous Administration Drug, in Healthy Volunteers and in Patients with Advanced Parkinson's Disease 6
(Date:6/19/2013)... 2013 Dental professionals are increasingly monitoring ... minor to moderate sedation, a patient’s breathing depth and ... is the latest to update its guidelines to require ... in an effort to increase safety in procedures. This ... Act goes into effect July 1. , The ...
(Date:6/19/2013)... June 19, 2013 DiscountFurnaceFilter.com, the number one ... offer the 5-2-1 Compressor Saver kit at an exceptional price. ... Kit) aids the air conditioning unit during start up, saving ... air compressor or unit burn out. , The 5-2-1 ... the air conditioner uses less power to start and drastically ...
(Date:6/19/2013)... (PRWEB) June 19, 2013 Guests at the ... wealthy and wise even if they don’t go to bed ... require some early thought. , Crafty travelers ... they take advantage of the pet-friendly Scottsdale Paradise Valley hotel’s ... . With at least 14 days advance notice, guests can ...
(Date:6/19/2013)... Washington (PRWEB) June 19, 2013 ... physicians deem it medically necessary, according to a ... and Child Health Journal. The results of this ... for more than a decade – that trying-to-conceive ... and maintaining a healthy body weight. Fairhaven Health ...
(Date:6/19/2013)... The motor neuron disease Amyotrophic lateral sclerosis (ALS), also ... sequential pattern which can be classified into four distinct ... at the University of Pennsylvania in the Annals ... and spinal cord tissues shows, for the first time, ... starting point in the central nervous system to other ...
Breaking Medicine News(10 mins):Health News:Required Capnography Monitoring Growing Trend Among National and State Healthcare Organizations 2Health News:Required Capnography Monitoring Growing Trend Among National and State Healthcare Organizations 3Health News:Plan Ahead and Save Big With New Deal From Residence Inn Scottsdale Paradise Valley 2Health News:Plan Ahead and Save Big With New Deal From Residence Inn Scottsdale Paradise Valley 3Health News:Plan Ahead and Save Big With New Deal From Residence Inn Scottsdale Paradise Valley 4Health News:Fairhaven Health's Dr. Amos Grunebaum Says Fertility Awareness Leads to Babies 2Health News:Fairhaven Health's Dr. Amos Grunebaum Says Fertility Awareness Leads to Babies 3Health News:Fairhaven Health's Dr. Amos Grunebaum Says Fertility Awareness Leads to Babies 4Health News:Staging system in ALS shows potential tracks of disease progression, Penn study finds 2
... dedicated to the health and well being of children, ... (FDA) has approved an investigational new drug application; ... topical solution for the treatment of head lice. ... professionals a new choice for the treatment of head ...
... cyclists will be participating in the Memory Ride for Alzheimer's ... to fight the disease that affects more than 5 ... 11th annual Memory Ride has a personal story to tell ... who has struggled with the disease. ,The Alzheimer's ...
... is not as squeaky-clean as she appears . ,In a ... she is quite the opposite of her supposed righteous image. ... Do you think you have a squeaky-clean image? Im like, Could ... Us Weekly quoted her, as telling the mag. ,I ...
... the University of Idaho is helping to increase understanding ... identify conditions that make women prone to infections and ... problems. ,Women suffer from insidious health problems, ... send them in droves to seek medical treatment, said ...
... the occurrence of anaphylaxis between the northern and southern ... be fatal without treatment with epinephrine. The striking ... risk, currently are without explanation. The investigators hypothesize, however, ... sunshine, may play a role and that this hypothesis ...
... can relieve people of shyness, and help them socialise with ... use, and an individual can boost self-confidence just by squirting ... that the spray harnesses the powers of a feel-good hormone ... in social recognition and bonding. ,The mammalian ...
Cached Medicine News:Health News:Vaginal Bacteria Vary Among Healthy Women 2Health News:Large Geographic Differences in EpiPen Prescriptions in the U. S. 2
It is designed for rigid skeletal fixation. These pins are constructed of stainless steel and can be removed for sterilization and reuse....
It is designed for rigid skeletal fixation. These pins are constructed of stainless steel and can be removed for sterilization and reuse....
It is designed for rigid skeletal fixation. These pins are constructed of stainless steel and can be removed for sterilization and reuse....
... designed for rigid skeletal fixation, ... freedom in positioning the fixation ... fixation is designed for the ... positions. Craniotomies can be performed ...
Medicine Products: