Tetra Bio-Pharma (TBPMF) Discusses FDA Orphan Drug Designation for Its Ophthalmic Program and Cannabinoid-Based Topical Cream

The Stock Day Podcast welcomed Tetra Bio-Pharma (OTCQB: TBPMF) (“the Company”), a biopharmaceutical leader in cannabinoid-based drug discovery and development with a Health Canada approved, and FDA reviewed and approved, clinical program aimed at bringing novel prescription drugs and treatments to patients and their healthcare providers. CEO of the Company, Dr. Guy Chamberland, joined Stock Day host Everett Jolly.

Jolly began the interview by asking about a recent press release by the Company confirming the renewal of a DEA Schedule 1 license for its QIXLEEF clinical site. “The way it works is that the Drug Enforcement Agency (DEA) has to approve the site even before we apply to the FDA,” explained Dr. Chamberland. “Once you get the drug approved for a trial by the FDA, the site then has to go back to the DEA and the DEA has to add that trial to your license,” he continued. “That was an essential one,” he added. “Now we have no more barriers.”

Jolly then asked about the Company’s FDA Orphan Drug Designation, which was received for their ophthalmic clinical program. “This was one came as kind of a surprise to me,” said Dr. Chamberland, noting that the program includes the treatment of serious ophthalmic conditions.

The conversation then turned to the Company’s cannabinoid-based topical cream, which also recently received an FDA Orphan Drug Designation. Dr. Chamberland shared that the Company planned to develop a pipeline of Orphan Designated products, which are protected for seven years if granted successfully. “That is key. Many biotechs go down this path,” said Dr. Chamberland.

“What are your plans for the second and third quarter?”, asked Jolly. “Our strength has been to prepare and submit our drug applications, as well as other regulatory applications,” said Dr. Chamberland. “You need to develop the science to convince the FDA that your drug can potentially work in this indication,” he explained, adding that proving the relevance of the drug to the FDA is another important part of the process. “A lot of people fail in getting orphan drugs because they can’t answer those questions.”

To close the interview, Dr. Chamberland shared that the Company has adapted well to the virtual demands of the COVID-19 pandemic, and continues to move forward with its clinical and regulatory submissions. “It’s great to see the hard work the company is putting in and the work that is actually being generated because everyone is focused on their job.”

To hear Dr. Guy Chamberland’s entire interview, follow the link to the podcast here: https://audioboom.com/posts/7563204-tetra-bio-pharma-discusses-fda-orphan-drug-designation-for-its-ophthalmic-program-and-cannabinoid

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About Tetra Bio-Pharma

Tetra Bio-Pharma (TSXV: TBP) (OTCQB: TBPMF) is a biopharmaceutical leader in cannabinoid-based drug discovery and development with a Health Canada approved, and FDA reviewed and approved, 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.

For more information visit: www.tetrabiopharma.com

Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture 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.