Tetra Bio-Pharma Inc (TSE:TBP) (OTCQB:TBPMF) (FRA:JAM1) revealed that it has advanced its REDUVO cannabinoid soft gel capsules New Drug Submission (NDS) file by responding to a request for more information from Health Canada.
The company had previously talked about Health Canada's request on March 15. “The review is part of the overall requirement for Tetra to be able to sell and distribute REDUVO soft gel capsules in Canada,” said the company.
REDUVO will allow Tetra to establish a revenue stream based on a synthetic cannabinoid drug for major markets in Chemotherapy-induced Nausea and Vomiting (CINV).
READ: Tetra Bio-Pharma's THC-based prescription drug completes Health Canada’s New Drug Submission screening phase
In a statement, Tetra CEO Dr Guy Chamberland said: "Our regulatory team was able to address the points raised and has submitted the response to Health Canada within the allowable timeframe. If the response is determined to be complete, the application will enter the next phase of review.”
“This is basically the scientific evaluation phase of the NDS application and is the final review phase of the review process. Having submitted the response within the allowable timeframe allows Tetra to maintain its anticipated launching of REDUVO in the second half of 2021."
On April 9, Tetra said it submitted all the requested information to the Office of Submissions and Intellectual Property (OSIP) and the Therapeutic Products Directorate (TPD) of Health Canada. “The additional information supporting the NDS and the proposed regulatory pathway have been provided as requested,” said the company, while adding that this will now allow Health Canada to “assess the requested information for completeness.”
A successful application will provide Tetra with its first Drug Identification Number (DIN) for a THC-based prescription drug. A DIN is a unique eight-digit number assigned to a drug that has undergone a robust assessment by Health Canada and is authorized for sale in Canada. The company anticipates that REDUVO will be publicly reimbursed by Canadian provinces and territories. The new drug name, REDUVO, is also under examination by Health Canada.
The addressable Canadian market for REDUVO is estimated at C$80 million by 2022, according to Compuscript Data. REDUVO will be aimed at battling AIDS-related anorexia associated with weight loss and severe nausea, and vomiting associated with cancer chemotherapy.
Tetra Bio-Pharma is a pioneer in immunomodulator drug discovery and development with a Food and Drug Administration (FDA) and a Health Canada-cleared clinical program aimed at bringing novel prescription drugs and treatments to patients.
Contact the author Uttara Choudhury at uttara@proactiveinvestors.com
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