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Tetra Bio-Pharma Provides Update on U.S. and Canadian Regulatory Activities
Tetra Bio-Pharma Provides Update on U.S. and Canadian Regulatory Activities.
About this update from Tetra Bio-pharma Inc.
[{"type":"text","content":"\n Submitted data to U.S. Food and Drug Administration for surrogate endpoint to be used for an Accelerated Approval              Two OTC DIN applications pass Health Canada screening phase OTTAWA, Dec. 19, 2019 (GLOBE NEWSWIRE) -- Tetra Bio-Pharma Inc. (“Tetra” or the “Company”) (TSX-V:TBP) (OTCQB:TBPMF), a leader in cannabinoid-derived drug discovery and development, today provided an update on its ongoing regulatory activities with both the U.S. Food and Drug Administration (FDA) and Health Canada.   In November 2019, Tetra provided additional data on CAUMZTM to the FDA as part of its Type B Meeting. The data demonstrate that a surrogate endpoint could be used to support drug approval under the Accelerated Approval pathway, potentially expediting patients’ access to important treatments for serious conditions. The FDA determined that this additional data was substantial and that the FDA needed additional time to complete its review, which now includes consulting its Surrogate Endpoint Committee.  FDA can allow the use of a surrogate endpoint that can predict clinical benefit, but is not itself a measure of clinical benefit.  \"We are extremely happy by the FDA’s response. We believe it signals FDA consideration of an Accelerated Approval and the additional review time is to carefully and adequately review this request,\" said Dr. Guy Chamberland, CEO and Chief Regulatory Officer of Tetra. “We anticipate FDA to complete its review before the end of January 2020.” Additionally, on the company’s two OTC DIN applications submitted to Health Canada in November, as highlighted in its press release on November 26, 2019, Tetra confirms that both applications have made it through the screening phase of the review process. Both applications are continuing through the review process and the company continues to anticipate commercial launch in Canada in pharmacy retail outlets in early 2020. About Tetra Bio-PharmaTetra Bio-Pharma (TSX-V:TBP) (OTCQB:TBPMF) is a biopharmaceutical leader in cannabinoid-based drug discovery and development with a Health Canada approved, and FDA reviewed, clinical program aimed at bringing novel prescription drugs and treatments to patients and their healthcare providers. The Compan...