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.
About Tetra Bio-Pharma Inc.
Tetra Bio-Pharma (TSX: TBP) (OTC-PINK: TBPMF) (FRA:JAM1) is a leader in cannabinoid-derived drug discovery and development with a FDA and a Health Canada cleared clinical program aimed at bringing novel prescription drugs and treatments to patients and their healthcare providers. Tetra’s evidence-based scientific approach has enabled them to develop a pipeline of cannabinoid-based drug products for a range of medical conditions, including pain, inflammation, and oncology. With patients at the core of what they do, Tetra is focused on providing rigorous scientific validation and safety data required for inclusion into the existing biopharma industry by regulators, physicians, and insurance companies.
Neither the TSX Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Exchange) accepts responsibility for the adequacy or accuracy of this release.
Some statements in this release may contain forward-looking information. All statements, other than of historical fact, that address activities, events or developments that the Company believes, expects or anticipates will or may occur in the future (including, without limitation, statements regarding potential acquisitions and financings) are forward-looking statements. Forward-looking statements are generally identifiable by use of the words “may”, “will”, “should”, “continue”, “expect”, “anticipate”, “estimate”, “believe”, “intend”, “plan” or “project” or the negative of these words or other variations on these words or comparable terminology. Forward-looking statements are subject to a number of risks and uncertainties, many of which are beyond the Company’s ability to control or predict, that may cause the actual results of the Company to differ materially from those discussed in the forward-looking statements. Forward-looking statements in this news release include, among other things, statements about: the anticipated filing of the audited annual financial statements and the approval of the management cease trade order by the Ontario Securities Commission. Factors that could cause actual results or events to differ materially from current expectations include, among other things, without limitation, the inability of the Company to obtain sufficient financing to execute the Company’s business plan, competition, regulation and anticipated and unanticipated costs and delays, the success of the Company’s research and development strategies, including the success of this product or any other product, the applicability of the discoveries made therein, the successful and timely completion and uncertainties related to the regulatory process, the timing of clinical trials, the timing and outcomes of regulatory or intellectual property decisions, the risk that the anticipated benefits from the receipt of funds from the Investor will not be realized as contemplated, or at all, and other risks disclosed in the Company’s public disclosure record on file with the relevant securities regulatory authorities. Although the Company has attempted to identify important factors that could cause actual results or events to differ materially from those described in forward-looking statements, there may be other factors that cause results or events not to be as anticipated, estimated or intended. Readers should not place undue reliance on forward-looking statements. The forward-looking statements included in this news release are made as of the date of this news release and the Company does not undertake an obligation to publicly update such forward-looking statements to reflect new information, subsequent events or otherwise unless required by applicable securities legislation.
For further information, please contact Tetra Bio-Pharma Inc.:
SOURCE Tetra Bio-Pharma Inc.
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