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OTTAWA, ON / ACCESSWIRE / December 30, 2020 / Tetra Bio-Pharma Inc. (“Tetra” or the “Company”) (TSX:TBP)(OTCQB:TBPMF), a leader in cannabinoid-derived drug discovery and development announced today that the New Drug Submission (NDS) for the Dronabinol Soft Gel capsules, has been filed with Health Canada. If successful, it will provide Tetra with its first Drug Identification Number (DIN) for a THC-based prescription drug. The new drug name, REDUVO™, is pending approval by Health Canada.
REDUVO™ will allow Tetra to establish a revenue stream based on a synthetic cannabinoid drug for major markets in Chemotherapy-induced Nausea and Vomiting (CINV). The addressable market is estimated to be $80M CDN by 20221. REDUVO™ will be indicated in AIDS-related anorexia associated with weight loss and severe nausea, and vomiting associated with cancer chemotherapy.
Dr. Guy Chamberland, CEO and CRO of Tetra commented, “We are pleased to have cleared this important regulatory milestone with Health Canada, bringing the NDS one step closer to a marketing authorization. Pending regulatory approval, Tetra anticipates launching REDUVO™ in the second half of 2021. Now that this important milestone has been achieved, we will expedite the PPP-002 505(b)(2) program.
About Tetra Bio-Pharma
Tetra Bio-Pharma (TSX:TBP)(OTCQB:TBPMF), is a biopharmaceutical leader in cannabinoid-based drug discovery and development with a FDA and a Health Canada approved clinical program aimed at bringing novel prescription drugs and treatments to patients and their healthcare providers. Our evidence-based scientific approach has enabled us 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 we 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. For more information visit: www.tetrabiopharma.com
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.
1 Compuscript Data 2020 (IQVIA) for total Nabilone market, combined with the expected penetration by REDUVO™
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