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February 7, 2014
14:03 EDTADHDAlcobra submits INDA with FDA for Phase III trial
Alcobra announced the submission of an Investigational New Drug Application with the U.S. FDA to initiate a Phase III clinical trial with MG01CI. "With the submission of this IND, the company has achieved an additional major milestone in its development program of MG01CI for ADHD and other cognitive disorders. Given the positive results in our two previous Phase II studies in adults with ADHD we look forward to working closely with the FDA to meet the remaining requirements necessary to bring this therapy to the market," said Dr. Yaron Daniely, president & CEO of Alcobra.
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August 19, 2014
08:05 EDTADHDAlcobra announces enrollment of first patient in Phase IIb clinical trial of MDX
Alcobra announced that the first patient has been enrolled in a Phase IIb Fragile X study of MDX. The FDA granted "Orphan Drug" designation to Metadoxine in the treatment of Fragile X Syndrome in December 2013. The Phase IIb Fragile X trial is a multi-center, randomized, placebo-controlled study and is being conducted in 11 clinical sites, primarily in the U.S. It is designed to investigate MDX for 6 weeks compared with placebo in 60 adolescent and adult subjects with Fragile X Syndrome.
August 14, 2014
10:05 EDTADHDSummer Street chief scientific officer holds an analyst/industry conference call
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