NetworkNewsBreaks – Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) Calls Meeting a ‘Milestone’ as FDA Affirms Alignment
Tonix Pharmaceuticals (NASDAQ: TNXP), a fully integrated biopharmaceutical company with marketed products and a pipeline of development candidates, has received formal minutes from its pre-New Drug Application (“NDA”) Type-B Chemistry, Manufacturing, and Controls (“CMC”) meeting with the U.S. Food and Drug Administration (“FDA”). Tonix met with the FDA regarding its product candidate Tonmya(TM), also known as TNX-102 SL, for the management of fibromyalgia. According to the announcement, the meeting was for Tonix Pharmaceuticals officials to identify alignment and agreement with the FDA on key CMC topics as the company prepared to submit an NDA to the FDA. “We remain encouraged…
