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Tetra Bio-Pharma Inc. (OTCMKTS: TBPMF) Receives Letter Granting Type C Meeting Discussing Labelling and Safety Needs of QIXLEEF



Tetra Bio-Pharma Inc. (OTCMKTS: TBPMF) has announced that the US Food and Drug Administration has granted a letter for a Type C meeting to go over the safety and labeling needs for marketing approval grant under the 505(b)(1) regulatory pathway for QIXLEEF.

QIXLEEF has a balanced ratio of THC to CBD 

QIXLEEF is a botanical inhaled experimental novel medication with a set THC and CBD ratio that complies with cGMP regulatory criteria in the United States. In addition, the aerosol produced by the Mighty Medic medical device meets the FDA’s delivered-dose uniformity (DDU) standards for inhalation aerosols (equally called metered-dose inhalers (or MDIs)) and inhalation powders (also popular as dry powder inhalers (or DPIs). The DDU is a calculation that compares the medication discharged from the mouthpiece of an inhalation device to the intended delivered dose. A quality inhaled medication product must adhere to the DDU criteria.

Tetra reported earlier this year that it had received a Scientific Advice Assessment (SAA) Report from the Malta Medicines Authority (MAA). The company’s drug development plan for QIXLEEF received excellent feedback in the Report, as did Tetra’s eligibility to submit a Marketing Authorization Application under Directive 2001/83/EC (Directive). Additionally, the SAA report endorsed the company’s recommended plan to address the nonclinical safety standards for filing an MAA for QIXLEEF.

Safety studies time consuming and can impact MAA submission 

These safety investigations are both expensive and time-consuming, and they might have an impact on when a marketing application is submitted.  The company has developed a pipeline of cannabinoid-based medicinal solutions for a variety of medical diseases, including inflammation, pain, and oncology, thanks to their evidence-based scientific approach.

Dr. Guy Chamberland, Tetra Bio-Pharma’s Chief Executive Officer (CEO) and Chief Regulatory Officer (CRO), 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.”

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