regulatory
confidence high
sentiment negative
materiality 0.60
Protagenic Therapeutics delays PT00114 clinical trial start to Q4 2021 after FDA request
Protagenic Therapeutics, Inc.new
- FDA requested ready-to-inject clinical vials instead of local formulation; company refiling IND.
- Patient enrollment now expected to begin in Q4 2021 (previously earlier timeline).
- Company states implementing FDA guidance adds benefit of controlling final drug product formulation.
- Press release dated July 23, 2021; IND filed June 29, 2021.