Navigation Links
Curemark LLC Announces Positive Pre-NDA Meeting With FDA for New Drug Application for CM-AT for Autism

RYE, N.Y., April 23, 2013 /PRNewswire/ -- Curemark LLC announced a successful pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration ("FDA") regarding its CM-AT treatment for Autism.

The meeting was held to discuss Curemark's Phase 3 trial results and the pathway for filing an NDA. In view of the positive guidance at this meeting, Curemark will begin filing its NDA. The FDA previously granted Curemark's CM-AT its FAST TRACK designation.

"We continue to work closely with the FDA and appreciate its guidance as we begin filing our New Drug Application for CM-AT for autism," commented Curemark's CEO Dr. Joan Fallon .

Dr. Fallon continued, "The Agency's recognition of the importance of our novel biomarker is equally exciting.  We look forward to taking the next steps in bringing this therapy to the children who need it." 

About Curemark LLC 

Curemark is a drug research and development company focused on the treatment of neurological and other diseases, especially those with dysautonomic components, by addressing certain key gastrointestinal/pancreatic secretory deficiencies. The company previously announced that its Phase III double blind randomized placebo controlled multicenter clinical trial of CM-AT for autism met its primary and secondary endpoints.  To learn more about our innovative science, visit

Safe-Harbor Statements

This news release contains forward-looking statements that involve risks and uncertainties that could cause our actual results and experiences to differ materially from anticipated results and expectations expressed in such forward-looking statement. These forward-looking statements include, without limitation, statements regarding the mechanism of action of the Curemark products CM-AT, CM-4612 and CM-182 their potential advantages, their potential for use in treating diseases or disorders, as well as the timing, progress and anticipated results of the clinical development and regulatory processes concerning the Curemark products CM-AT, CM-4612 and CM-182. These statements are based on our current beliefs and expectations as to such future outcomes, and are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. Factors that might cause such a material difference include, among others, risks that the results of clinical trials will not support our claims or beliefs concerning the effectiveness of the Curemark products CM-AT, CM-4612 and CM-182, our ability to finance our development of CM-AT, CM-4612 and CM-182 regulatory risks, and our reliance on third party researchers and other collaborators. We assume no obligation to update these statements, except as required by law.


Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Curemark Announces Executive Promotions
2. Precision Optics Corporation Announces $1 Million Order for Microprecision™ Based Endoscopes
3. Young Innovations, Inc. Announces Record Sales and EPS for the Quarter Ended March 31, 2012
4. JDRF Announces Research Collaboration with Dexcom, Inc. to Develop "Smart Transmitter" Technology to Accelerate Artificial Pancreas Studies
5. Misonix Announces New Distribution Agreement For Panama
6. University of Maryland BioPark Announces MedImmunes Dr. Bahija Jallal as Newest Member of Board of Directors for UM Health Sciences Research Park
7. Novelos Therapeutics Announces Successful Completion of First Cohort In Lung Cancer Trial With I-124-CLR1404 (LIGHT) Cancer-Targeted PET Imaging Agent at UW Carbone Cancer Center
8. Boston Scientific Announces CE Mark and European Launch of Emerge™ PTCA Dilatation Catheter
9. Soligenix Announces Further Progress with ThermoVax™ for Long-Term Vaccine ThermoStability
10. Masimo Announces New Low-Profile Infant and Neonatal Pulse Oximetry Sensors
11. Anthera Announces the Completion of Patient Dosing in Phase 2b PEARL-SC Study
Post Your Comments:
(Date:9/27/2017)... , Sept. 27, 2017  DarioHealth Corp. (NASDAQ: DRIO), a leading global ... that its MyDario product is expected to appear on The Dr. Oz ... Dr. Oz Show airs in your area: ... The nine-time Emmy award-winning, The Dr. Oz Show kicked ... The segment features ...
(Date:9/22/2017)... -- AVACEN Medical (AVACEN) announced that its CE-Marked AVACEN ... with the widespread pain associated with fibromyalgia in the ... Essex, England commented, "I had difficulty ... sleep at all, tremendous pain, with every movement sending ... AVACEN 100] enough, how this has and is helping ...
(Date:9/13/2017)... 2017   OrthoAtlanta has been named the official ... Committee (AFHC) for the 2018 College Football Playoff (CFP) National ... Mercedes-Benz Stadium in Atlanta, Georgia . OrthoAtlanta ... In" campaign, participating in many activities leading up to, and ... ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... October 13, 2017 , ... Ellevate Network, the leading network for professional women, ... towards gender equality at their inaugural Summit in New York City in June. The ... social audience of over 3 million. To watch the Mobilize Women video, click ...
(Date:10/13/2017)... ... October 13, 2017 , ... “The Journey: From the Mountains to ... to save lost souls in the Philippines. “The Journey: From the Mountains to the ... teacher of the Bible. She has taught all ages and currently teaches a class ...
(Date:10/12/2017)... ... October 12, 2017 , ... ... the demand of today’s consumer and regulatory authorities worldwide. From Children’s to Adults ... tested to meet the highest standard. , These products are also: Gluten ...
(Date:10/12/2017)... ... October 12, 2017 , ... ... Restoration, has recently contributed a medical article to the newly revamped Cosmetic ... Mohebi’s article spotlights the hair transplant procedure known as Follicular Unit Extraction ...
(Date:10/12/2017)... ... October 12, 2017 , ... ... first interactive health literacy software tool, and the Cancer Patient Education Network (CPEN), ... patient education, today announce a new strategic alliance. , As CPEN’s strategic ...
Breaking Medicine News(10 mins):