Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to TNX-102 SL* for the treatment of posttraumatic stress disorder (PTSD).

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The benefits of Breakthrough Therapy designation include the eligibility for priority review of the New Drug Application (NDA) within 6 months instead of 10 months and rolling submission of portions of the NDA, in addition to an organizational commitment involving FDA's senior managers contributing significant guidance. The FDA is committing to provide Tonix timely advice and interactive communications related to the design and efficient execution of a drug development program.

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