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TEL AVIV, Israel, Dec. 14, 2016 -- Alcobra Ltd. (Nasdaq:ADHD), an emerging pharmaceutical company focused on the development of new medications to treat patients with cognitive disorders, including Attention Deficit Hyperactivity Disorder (ADHD) and Fragile X Syndrome, announced today that it recently held a productive face-to-face meeting with the Division of Psychiatry Products (DPP) of the U.S. Food and Drug Administration (FDA) to discuss their decision to place a full clinical hold on the development programs of Metadoxine Extended Release (MDX), and paths to resume human clinical trials with MDX. The Company expects to provide further details regarding the MDX regulatory path upon receipt of final meeting minutes from the DPP in the coming weeks.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and other Federal securities laws. Because such statements deal with future events and are based on Alcobra's current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of Alcobra could differ materially from those described in or implied by the statements in this press release. For example, forward-looking statements include statements regarding the clinical hold on the Company’s development programs of MDX and timing and content of future communications with the FDA and investors. In addition, historic results of scientific research do not guarantee that the conclusions of future research would not suggest different conclusions or that historic results referred to in this press release would not be interpreted differently in light of additional research or otherwise. The forward-looking statements contained or implied in this press release are subject to other risks and uncertainties, including those discussed under the heading "Risk Factors" in Alcobra Ltd.'s Annual Report on Form 20-F for the fiscal year ended December 31, 2015, filed with the Securities and Exchange Commission (SEC) and in subsequent filings with the SEC. Except as otherwise required by law, Alcobra disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date they were made, whether as a result of new information, future events or circumstances or otherwise.
U.S. Investor Contacts LifeSci Advisors, LLC Michael Rice 646-597-6979 [email protected] Media Inquiries Sam Brown, Inc. Mike Beyer 312-961-2502 [email protected] Israel Investor Contact: Alcobra Investor Relations Debbie Kaye +972-72 2204661 [email protected]
