Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP)
Post# of 112
http://www.streetinsider.com/Corporate+News/T...54101.html
Quote:
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.