Silo Pharma Completed Pre-investigational New Drug Meeting With FDA For SPC-15, An Intranasal Prophylactic Treatment For Post-traumatic Stress Disorder And Stress-induced Anxiety Disorder
Author: Benzinga Newsdesk | September 10, 2024 06:36am
The primary purpose of the pre-IND meeting was to align with the FDA on the 505(b)(2) regulatory pathway for approval of SPC-15 along with Silo's proposed plan to support opening an IND. The FDA's 505(b)(2) drug development route can significantly shorten clinical timelines for FDA approval and reduce drug development costs.
Posted In: SILO