(TheNewswire)

 
 
 

MONTREAL, QUEBEC – TheNewswire – May 11, 2023 -- Tetra Bio-Pharma Inc. ("Tetra" or the "Company") (TSX:TBP) (OTC:TBPMF) (FRA:JAM1), a leader in cannabinoid-derived drug discovery and development, today announced it has cancelled its New Drug Submission (NDS) to Health Canada, without prejudice to a refiling once it has completed a new clinical trial that addresses deficiencies raised by the regulator.

The NDS was intended to seek marketing approval in Canada for REDUVO™, a therapy for chemotherapy-induced nausea and vomiting. Health Canada’s review of the NDS raised issues regarding the submitted Phase 1 clinical and analytical data that had been performed more than 15 years ago. Clinical research standards have evolved since the conduct of the trial and Health Canada questioned if the trial would meet today’s standards for drug approval.  

The Company assessed the regulatory risk of maintaining its NDS in a revision status. By cancelling the application, the Company will be able to resubmit without prejudice.