Tetra Bio-Pharma (TSXV:TBP) announced an acceleration on the application process for two of its cannabis drug products.
As quoted in the press release:
Tetra Bio-Pharma, a global leader in cannabinoid-based drug development and discovery, announced today that it is accelerating the submission of a pre-marketing application for the registration of its cannabis drugs PPP001 and PPP005 under Directive 2001/83/EC of the European Parliament and of the Council.
This directive provides Tetra Bio-Pharma with the legal and regulatory framework needed to submit its pre-marketing application for its cannabis drugs. According to Dr. Guy Chamberland, Interim CEO and CSO, “the corporation has performed its own clinical trials and has sufficient quality and clinical trial data to initiate the application for the registration of PPP001 and PPP005 under the Directive 2001/83/EC. Tetra intends to pursue a Full Market Authorization since it has a dossier supporting the medicinal product’s quality, safety, and efficacy.”
All of Tetra’s clinical trials were performed with the same quality of evidence required by the National Competent authorities approving medicines/drugs. Tetra has completed several well-designed safety, pharmacodynamic and pharmacokinetic studies in healthy volunteers and also has two ongoing, well-designed clinical trials in patients. These trials are all double-blind, randomized and placebo controlled.