On December 22, 2022 Tetra Bio-Pharma Inc. ("Tetra" or the "Company") (TSX: TBP) (OTCQB: TBPMF) (FRA: JAM1) a leader in cannabinoid-derived drug discovery and development reported that it is providing its shareholders with another regulatory update on the REDUVO New Drug Submission (NDS) (Press release, Tetra Bio Pharma, DEC 22, 2022, View Source [SID1234625556]). The last update was provided on November 18, 2022.

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On December 21, 2022, the Company received a second Clarification Request (Clarifax) from Health Canada regarding the product’s Risk Management Plan, which is not atypical for a controlled substance drug. The Company will be submitting the response to Health Canada within the allowed timeframe. The Company cannot comment on Health Canada’s response timelines. Questions/feedback from Health Canada are received as the review of the dossier progresses through different review streams.

About REDUVO

REDUVO is a soft gel capsule used to treat chemotherapy-induced nausea and vomiting (CINV). It is also used to treat weight loss and severe nausea in people living with HIV infection. The active pharmaceutical ingredient in REDUVO is dronabinol, also known as THC, a synthetic form of the active natural substance in cannabis. REDUVO 5-year cumulative gross sales expected to reach $121M.