Tetra Bio-Pharma (CNSX:TBP) has announced that the Therapeutic Products Directorate of Health Canada approved its Phase I clinical study of PPP001 covering smoked cannabis for pain management in cancer and AIDS patients.
As quoted in the press release:

The announcement was followed one week later by the beginning of the trial, as Tetra was clearly ready to get going. The trial is a first study approved that could eventually lead to approval of the product as a prescription drug. The study assesses single and 7-day multiple daily ascending doses of smoked cannabis on the cognitive function in healthy adults.
It is the first development program aiming to obtain prescription drug approval and government provided insurance coverage for medical marijuana patients. If successful, the approval would set Tetra apart from all other medical marijuana providers who cannot get government provided insurance coverage and reimbursement for their patients. This could prove to be a major value driver for the company, as the lack of reimbursement is a serious obstacle for many patients seeking treatment.
Tetra Bio-Pharma also recently completed a pre-IND meeting with the United States Food & Drug Administration (“FDA”) Division of Anesthesia, Analgesia, and Addiction Products (“DAAAP”) Center for Drug Evaluation and Research (“CDER”) in late-January. During the meeting, the FDA provided guidance on the design of Phase I clinical trials and the overall program, while validating that the company was on the right track.


Click here to read the full press release.

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  • On November 19 , the Mexican Senate passed comprehensive adult-use cannabis legalization, moving Mexico towards becoming one of the few countries to legalize cannabis nationally
  • On March 31, 2020 , the Company entered into an agreement with Tecnologico de Monterrey , the leading university in Mexico , to educate physicians across Latin America , in advance of the impending regulations in Mexico
  • To date, close to 550 LatAm physicians have obtained their diploma accrediting completion of Khiron’s medical education program
  • The Company plans to deploy its ZereniaTM medical cannabis clinics and telehealth strategy in Mexico , building on the success of its vertical integration strategy in Colombia
  • Expanding the Zerenia clinic strategy will build on the Company’s Colombia knowledge and proven distribution capabilities, with rapid telehealth service adoption and over 5,600 medical cannabis scripts filled to date
  • Mexico represents one of the largest potential markets for medical cannabis in the world and is anticipated to reach $1.2bn USD by 2028 (Prohibition Partners).
  • Company to release Q3 2020 financials and host webcast on Tuesday, December 1st

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