Tetra Bio-Pharma Provides Update on U.S. and Canadian Regulatory Activities
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-Pharma
Tetra 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 Company has several subsidiaries engaged in the development of an advanced and growing pipeline of Bio Pharmaceuticals, Natural Health and Veterinary Products containing cannabis and other medicinal plant-based elements. 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 bio pharma industry by regulators, physicians and insurance companies.
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Source: Tetra Bio-Pharma
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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.
For further information, please contact Tetra Bio-Pharma Inc.:
Investor Contact:
Bruce Mackle
LifeSci Advisors LLC
646-889-1200
Media Contact:
Andrew Mielach
LifeSci Public Relations
646-876-5868
Canada:
Carol Levine
Energi PR
514-288-8500 ext. 226
