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Curemark LLC Announces Positive Pre-NDA Meeting With FDA for New Drug Application for CM-AT for Autism
Date:4/23/2013

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 www.curemark.com

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
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SOURCE Curemark LLC
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