Tonix Pharmaceuticals (TNXP) shares are up sharply after the company announced clear path to registration for TNX-102 SL (cyclobenzaprine HCl sublingual tablets) for the treatment of post-traumatic stress disorder (PTSD). TNXP said that based on the written minutes received from the FDA from its End-of-Phase 2/Pre-Phase 3 meeting, the agency confirmed that positive results from two Phase 3 trials along with safety studies should be sufficient to demonstrate efficacy for PTSD. The FDA agreed that the company's CMC (chemistry, manufacturing and controls) and nonclinical studies it previously accepted for the fibromyalgia NDA will be valid for the NDA for PTSD. The FDA also agreed that the company's CMC (chemistry, manufacturing and controls) and nonclinical studies it previously accepted for the fibromyalgia NDA will be valid for the NDA for PTSD.