11 May 2023 - Tetra Bio-Pharma today announced it has cancelled its new drug submission to Health Canada, without prejudice to a refiling once it has completed a new clinical trial that addresses deficiencies raised by the regulator.

The new drug submission 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.

Read Tetra Bio-Pharma press release