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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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July 15, 2014
10:28 EDTADHDHigh option volume stocks
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July 14, 2014
17:29 EDTADHDAlcobra files to sell $100M of ordinary shares
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09:15 EDTADHDAlcobra management to meet with Maxim
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08:11 EDTADHDAlcobra completes patient recruitment in Phase III clinical trial of MDX
Alcobra announced that recruitment of patients has been completed in the company's Phase III clinical trial of Metadoxine Extended Release, or MDX, in adult ADHD patients. The study is a 300-patient, randomized, placebo-controlled trial conducted at 18 sites in the United States and 2 in Israel. Patients were randomized to receive either 1400 mg MDX or placebo over 6 weeks following a 2-week screening period. The primary endpoint is the Conners' Adult ADHD Rating Scale, or CAARS-INV, a widely accepted clinical measure of the presence and severity of ADHD symptoms. Secondary endpoints include the computerized TOVA, or Test of Variables of Attention, which was also used in the previous Phase 2 studies, as well as safety assessments and additional exploratory endpoints.

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