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Tetra Bio-Pharma Receives Positive Scientific Advice Assessment (SAA) Report for QIXLEEF™

  • SAA Report endorsed Tetra Bio-Pharma's proposed nonclinical development and quality programs for QIXLEEF™.
  • SAA Report provides clarity on clinical requirements for registration in Europe.

OTTAWA, ON, Sept. 2, 2021 /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 pleased to announce that it received the Scientific Advice Assessment (SAA) Report from the Malta Medicines Authority.  Overall, the SAA Report provided positive feedback on Tetra's drug development plan for QIXLEEF™ and eligibility for submitting a Marketing Authorization Application (MAA) under Directive 2001/83/EC (Directive). QIXLEEF™ is the Company's inhaled proprietary drug which has a fixed ratio of THC and CBD. The medication is inhaled through a Class II medical vaporizer.

The SAA Report endorses Tetra's proposed plan to address the nonclinical safety requirements for submitting a MAA for QIXLEEF™. Similarly, the SAA Report endorses the Company's quality program for QIXLEEF™ as a medicine.  In both cases, the SAA Report provides guidance on requirements for MAA approval. 

The SAA Report discusses the assessment of both the PLENITUDE© and REBORN© clinical programs with regards to a MAA.  The SAA Report provides guidance on the endpoints and other aspects of the protocol. The REBORN2© trial was identified as pivotal for the MAA because of its dose-response endpoint requirements of the Directive.  Depending on the outcome in the REBORN1© and REBORN2© clinical trials, full Marketing Authorization would require confirmation of the outcome of REBORN1©.

Dr. Guy Chamberland, Chief Executive Officer and Chief Regulatory Officer of Tetra Bio-Pharma said "the endorsement of the proposed nonclinical and quality programs is an exciting achievement that affirms the robustness of our drug development approach. The Medicine Authority's response confirms that our development strategy, adjusted with their guidance on the clinical program, could allow QIXLEEF™ to satisfy the requirements of article 8 of the Directive.  The timing of this news is important for us as we try to finalize a single global clinical program for bringing QIXLEEF™ to patients."

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. 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.

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Forward-looking statements
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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