Ketabet (ketamine/betaine anhydrous) / PharmaTher - LARVOL DELTA

PharmaTher Provides Product Pipeline Updates and Anticipated Milestones for Q4-2021 and 2022 (Yahoo Finance) - "The Company has finalized the Phase 2 clinical study protocol to evaluate KETABET™ for treatment-resistant depression. The Company is working with its scientific and clinical advisor, Dr. Maurizio Fava, MD, with the aim to complete the IND and file it with the FDA in early October...The Company has already activated start-up activities and identified potential clinical sites to screen and enroll patients for the proposed Phase 2 clinical study in Q4-2021. The aim is to share initial clinical results by the end of this year. Assuming the Phase 2 clinical study 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 in the first half of 2022."

IND • New P2 trial • New P3 trial • P2 data • CNS Disorders • Depression