QIXLEEF™ Aerosol Meets the Criteria Established by the U.S. FDA for Delivery of Inhalation Aerosols

Rhea-AI Summary

Tetra Bio-Pharma announced a Type C meeting with the FDA to discuss marketing authorization requirements for its investigational inhaled drug, QIXLEEF™. This drug, which combines THC and CBD, meets the FDA’s standards for inhalation aerosols. The company received positive feedback from the Malta Medicines Authority earlier this year, confirming the adequacy of its nonclinical safety strategy. CEO Guy Chamberland emphasized the importance of FDA guidance to ensure cost-effective market entry for QIXLEEF™. Tetra Bio-Pharma focuses on cannabinoid-derived drug development for various medical conditions.

Positive

• FDA granted a Type C meeting to discuss marketing authorization for QIXLEEF™.
• QIXLEEF™ meets USA cGMP regulatory requirements.
• Positive feedback received from Malta Medicines Authority on drug development plan.

Negative

• Safety studies for QIXLEEF™ are time-consuming and costly, potentially impacting the marketing application timeline.

• Tetra Bio-Pharma Confirms Meeting with the FDA to Align on the Requirements for Marketing Authorization

OTTAWA, ON, Nov. 29, 2021 /PRNewswire/ - Tetra Bio-Pharma Inc. ("Tetra" or the "Company") (TSX: TBP) (OTCQB: TBPMF) (FRA: JAM1), a leader in cannabinoid-derived drug discovery and development today announced that it received a letter from the United States Food and Drug Administration (FDA), granting a Type C meeting to discuss safety and labelling requirements for obtaining marketing approval under the 505(b)(1) regulatory pathway for its QIXLEEF™.

QIXLEEF™ is a botanical inhaled investigational new drug with a fixed ratio of THC and CBD that meets USA cGMP regulatory requirements. The delivered-dose uniformity (DDU) of the aerosol generated by the Mighty Medic® medical device meets the criteria established by FDA for inhalation aerosols (also known as metered dose inhalers (or MDIs)) and inhalation powders (also known as dry powder inhalers (or DPIs)). The DDU is a measure of the drug discharged from the mouthpiece of an inhalation device and compares that measurement to the target delivered dose. Meeting the DDU specification is critical for a quality inhaled drug product.

Earlier this year, Tetra announced it received from the Malta Medicines Authority (MAA) a Scientific Advice Assessment (SAA) Report. The 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). The SAA Report endorsed Tetra's proposed plan to address the nonclinical safety requirements for submitting a marketing approval application for QIXLEEF™.

These safety studies are both time consuming and very costly and can impact the timing of the submission of a marketing application. Dr. Guy Chamberland, Chief Executive Officer (CEO) and Chief Regulatory Officer (CRO) of Tetra Bio-Pharma said "the MAA's response confirmed that our nonclinical safety strategy is acceptable and would satisfy the requirements of article 8 of the Directive. Now we need to obtain the FDA's final guidance on this strategy to ensure QIXLEEF™ makes it to the market at the lowest cost."

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.

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.

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.

FAQ

What is the latest news about Tetra Bio-Pharma on November 29, 2021?

Tetra Bio-Pharma announced a meeting with the FDA to discuss the marketing authorization requirements for its drug QIXLEEF™.

What is QIXLEEF™ and its significance?

QIXLEEF™ is a cannabinoid-based inhaled drug that meets FDA standards for inhalation aerosols and is critical for Tetra's market strategy.

What feedback did Tetra Bio-Pharma receive from the Malta Medicines Authority?

Tetra received positive feedback confirming that their nonclinical safety strategy is acceptable for marketing approval.

How does the FDA involvement affect Tetra Bio-Pharma's stock TBPMF?

The FDA's guidance on QIXLEEF™ could significantly impact its market entry costs and timelines, influencing investor confidence.