regulatory
confidence high
sentiment positive
materiality 0.60
Bioxytran receives CDSCO approval for Phase 1b/2a trial of ProLectin-M in COVID-19 patients
BIOXYTRAN, INC
- IND authorization from India's CDSCO for a Phase 1b/2a randomized, blinded, placebo-controlled study of ProLectin-M in mild-to-moderate COVID-19.
- Trial will evaluate safety, efficacy, and pharmacokinetics of oral ProLectin-M; results to guide a 408-patient Phase III trial.
- Condition: each site must obtain Ethics Committee approval before starting enrollment.
- Press release issued December 8, 2022.