09:06 AM EST - PharmaTher Holdings Ltd. : Announced that the U.S. Food and Drug Administration has approved the Company’s Investigational New Drug application to proceed with a Phase 2 clinical trial to evaluate the safety, efficacy and pharmacokinetics of ketamine in the treatment of levodopa-induced dyskinesia in patients with Parkinson’s disease. PharmaTher expects to begin enrolling patients in the Phase 2 clinical trial in Q3-2021. Assuming the Phase 2 clinical trial is positive, the Company will request a meeting with the FDA to discuss its plan and obtain an agreement to move to a Phase 3 clinical study under the 505(b)(2) regulatory pathway next year. PharmaTher Holdings Ltd.
shares C.PHRM are trading unchanged at $0.19.
