BetterLife Pharma CEO Ahmad Doroudian joined Steve Darling from Proactive to share news the company has received a written response from the U.S. FDA on its pre-investigational new drug application for the treatment of MDD with BETR-001.
Doroudian telling Proactive the FDA’s response is in general agreement with the Company’s planned program for the development of BETR-001 and provided guidance regarding the BETR-001 IND-enabling non-clinical toxicology studies, its manufacturing strategy, and initial proposed clinical trial parameters.