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Wednesday, 01/03/2018 8:54:21 AM

Wednesday, January 03, 2018 8:54:21 AM

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VTGN GREAT NEWS
SOUTH SAN FRANCISCO, CA--(Marketwired - January 03, 2018) - VistaGen Therapeutics, Inc. (VTGN), a clinical-stage biopharmaceutical company focused on developing new generation medicines for depression and other central nervous system (CNS) disorders, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to AV-101 for development as a potential adjunctive treatment for Major Depressive Disorder (MDD). The FDA's Fast Track process is designed to facilitate the development and review of new treatments for serious conditions with unmet medical need such as MDD.
"Fast Track Designation is another important regulatory milestone for our AV-101 program for MDD, providing us the opportunity for frequent interactions with the FDA focused on the most appropriate and efficient development pathway to bring AV-101 to MDD patients," said Shawn Singh, Chief Executive Officer of VistaGen. "We are on track to dose the first patient in our AV-101 Phase 2 MDD adjunctive treatment study in the first quarter of 2018."
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