- Second Clarifax received from Health Canada.
MONTREAL, Dec. 22, 2022 /CNW/ - Tetra Bio-Pharma Inc. ("Tetra" or the "Company") (TSX: TBP) (OTCQB: TBPMF) (FRA: JAM1) a leader in cannabinoid-derived drug discovery and development is providing its shareholders with another regulatory update on the REDUVO™ New Drug Submission (NDS). The last update was provided on November 18, 2022.
On December 21, 2022, the Company received a second Clarification Request (Clarifax) from Health Canada regarding the product's Risk Management Plan, which is not atypical for a controlled substance drug. The Company will be submitting the response to Health Canada within the allowed timeframe. The Company cannot comment on Health Canada's response timelines. Questions/feedback from Health Canada are received as the review of the dossier progresses through different review streams.
REDUVO™ is a soft gel capsule used to treat chemotherapy-induced nausea and vomiting (CINV). It is also used to treat weight loss and severe nausea in people living with HIV infection. The active pharmaceutical ingredient in REDUVO™ is dronabinol, also known as THC, a synthetic form of the active natural substance in cannabis. REDUVO™ 5-year cumulative gross sales expected to reach $121M.
About Tetra Bio-Pharma
Tetra Bio-Pharma (TSX: TBP) (OTCQB: 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. Their 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 Bio-Pharma 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. 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 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.
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SOURCE Tetra Bio-Pharma Inc.
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