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Tetra Bio-Pharma to Present Key Research Findings as Part of Food and Drug Administration (FDA) Public Hearing on CBD
Tetra Bio-Pharma to Present Key Research Findings as Part of Food and Drug Administration (FDA) Public Hearing on CBD.
About this update from Tetra Bio-pharma Inc.
[{"type":"text","content":"\nOTTAWA, May 30, 2019 (GLOBE NEWSWIRE) -- Tetra Bio-Pharma Inc. (\"Tetra\" or the \"Company\"), a leader in cannabinoid-based drug discovery and development (TSX VENTURE: TBP) (OTCQB: TBPMF), will present key findings from its three Phase 1 and its Phase 2 cancer and non cancer investigational trials with cannabinoids,  before the Food and Drug Administration’s (FDA) Scientific Data and Information about Products Containing Cannabis or Cannabis-Derived Compounds,  Part 15 Public Hearing on Friday, May 31, 2019. The meeting will take place in Silver Spring, Maryland.\n The goal of the hearing is to obtain additional scientific data and other information related to cannabis and cannabis-derived compounds to inform the FDA’s regulatory oversight of these products. This hearing is particularly important considering the passage of the Agriculture Improvement Act of 2018, Public Law 115-334 (so called Farm Bill), which, among other things, removed the plant Cannabis sativa L. or “hemp” from the Controlled Substances Act. Given the lack of safety evidence in the published literature, the FDA will hear from important stakeholders including patients, academia, manufacturing, retailers, public health and government bodies who will contribute by providing their data and experience. More than 400 different groups and entities made requests to present before the hearing. Tetra’s presentation will be made by Rola Mazloum, Director of Regulatory Affairs and will comprise but not be limited to the following: Demonstrate that: inhalation via smoke or vapor achieves significantly superior delivery to the patient than the oral or sublingual routes; the oral route with capsules achieves less absorption than that of sublingual delivery; Provide a comparison of: side effects when given single dose versus repeat daily dosing. smoked versus vaped product; Present pertinent safety findings from the Phase 1 trials;Provide data that suggests a mechanism of tolerance to side effects;Present the impact of dose titration comparing smoked versus oral;Summarize the mycotoxin (fungi impurities) findings and how Tetra now manages this issue. “The ground-breaking research that Tetra has and continues to advance is critical in adding to the scientific safety and efficacy data that regulators like the FD...