July 5, 2022

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Tetra Bio-Pharma Presents Position of Its New Drug Submission Application in Canada

  • Reduvo™ would be Canada’s only DIN for a THC-centered prescription drug
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  • The addressable current market is believed to be $80M CDN by 2022
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OTTAWA, ON / ACCESSWIRE / March 15, 2021 / Tetra Bio-Pharma Inc. (“Tetra” or the “Enterprise“) (TSX:TBP)(OTCQB:TBPMF), a biopharmaceutical pioneer in immunomodulator drug discovery and growth announce that the Dronabinol Gentle Gel capsules New Drug Submission (NDS) file submitted to Wellbeing Canada on December 30, 2020 has concluded the screening phase.

The file at Well being Canada done the screening phase. To aid the merchandise acceptance, and due to the nature of the info supporting the NDS, Wellness Canada has suggested an unconventional regulatory pathway and thus asked for extra details to satisfy all needs of that proposed prescription drug approval pathway. The optimistic opinions and conversation been given from Wellbeing Canada, which are aspect of the regular evaluate procedure, do not maximize the anticipated critique timeline. Tetra is doing work towards publishing the reaction to Wellbeing Canada in the allowable timeframe.

A effective software will supply Tetra with its first Drug Identification Variety (DIN) for a THC-centered prescription drug. The new drug title, REDUVO™, is also below evaluation by Health Canada.

REDUVO™ will make it possible for Tetra to set up a income stream based on a synthetic cannabinoid drug for significant markets in Chemotherapy-induced Nausea and Vomiting (CINV). The addressable Canadian current market is approximated to be $80M CDN by 20221. REDUVO™ will be indicated in AIDS-related anorexia associated with bodyweight decline and significant nausea, and vomiting connected with most cancers chemotherapy.

Dr. Dude Chamberland, CEO and CRO of Tetra commented, “We are delighted to have efficiently cleared this essential phase in the NDS software. The application will now enter the subsequent stage of evaluation, thus allowing Tetra to maintain its anticipated launching of REDUVO™ in the second 50 % of 2021. This drug start for Tetra is a important milestone as it moves the Enterprise from a pre-profits biotech to in income for 2021 which is wonderful news for Tetra personnel and shareholders. We anticipate solid demand for the only THC-based mostly drug in Canada that will be recommended by medical professionals. Through an intense Market place Access Method, Tetra anticipates that REDUVO™ will be publicly reimbursed by provinces and territories in Canada.”

About Tetra Bio-Pharma

Tetra Bio-Pharma (TSX:TBP)(OTCQB:TBPMF) is a biopharmaceutical pioneer in immunomodulator drug discovery and enhancement with a Fda and a Wellbeing Canada cleared scientific program aimed at bringing novel prescription medication and treatment plans to individuals and their healthcare providers. Our proof-primarily based scientific solution has enabled us to build a pipeline of cannabinoid-based mostly drug goods for a assortment of health care conditions, including suffering, inflammation, and oncology. With individuals at the main of what we do, Tetra Bio-Pharma is focused on giving arduous scientific validation and safety facts expected for inclusion into the present biopharma business by regulators, medical professionals and insurance coverage firms. For far more info pay a visit to: www.tetrabiopharma.com.

Neither the TSX Exchange nor its Regulation Expert services Company (as that time period is defined in the policies of the TSX Exchange) accepts accountability for the adequacy or accuracy of this launch.

Ahead-searching statements

Some statements in this launch might incorporate ahead-hunting information and facts. All statements, other than of historic truth, that tackle functions, functions or developments that the Enterprise thinks, expects or anticipates will or may perhaps come about in the future (together with, with out limitation, statements regarding possible acquisitions and financings) are ahead-seeking statements. Ahead-seeking statements are commonly identifiable by use of the words and phrases “could”, “will”, “need to”, “carry on”, “hope”, “anticipate”, “estimate”, “imagine”, “intend”, “system” or “challenge” or the damaging of these terms or other variations on these words and phrases or comparable terminology. Forward-wanting statements are topic to a number of dangers and uncertainties, many of which are outside of the Firm’s capability to control or predict, that may possibly lead to the true benefits of the Organization to vary materially from individuals talked about in the forward-hunting statements. Elements that could lead to true results or activities to vary materially from present expectations consist of, amid other matters, devoid of limitation, the lack of ability of the Company to get hold of ample financing to execute the Firm’s small business strategy opposition regulation and predicted and unanticipated prices and delays, the results of the Firm’s analysis and development approaches, including the achievement of this product or any other solution, the applicability of the discoveries created therein, the productive and well timed completion and uncertainties relevant to the regulatory method, the timing of medical trials, the timing and results of regulatory or intellectual home selections and other challenges disclosed in the Company’s general public disclosure record on file with the pertinent securities regulatory authorities. Whilst the Business has tried to identify significant things that could cause real effects or functions to vary materially from individuals described in forward-wanting statements, there may perhaps be other aspects that induce final results or functions not to be as anticipated, believed or meant. Viewers should not put undue reliance on ahead-hunting statements. The forward-looking statements provided in this news release are produced as of the day of this information release and the Firm does not undertake an obligation to publicly update these kinds of forward-on the lookout statements to replicate new info, subsequent events or if not until required by relevant securities laws.

1 Compuscript Info 2020 (IQVIA) for total Nabilone market, mixed with the anticipated penetration by REDUVO™

For additional data, be sure to speak to Tetra Bio-Pharma Inc.:

Tetra Bio-Pharma Inc.
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Ms. Natalie Leroux
Cellphone: + 1 (833) 977-7575
E mail: [email protected]

Resource: Tetra Bio-Pharma

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See source variation on accesswire.com:
https://www.accesswire.com/635381/Tetra-Bio-Pharma-Supplies-Standing-of-Its-New-Drug-Submission-Application-in-Canada