Tuesday, December 12, 2017 9:51:54 AM
"Tetra continues to expect PPP001 to become the first cannabis-derived inhalation drug to receive a drug identification number (DIN) from Health Canada, as well as pharmaceutical drug status from the FDA."
...Tetra received approval for the ethics review board on November 6th and subsequently submitted a Clinical Trial Application (CTA) for its Phase 3 clinical trial in cancer patients. This trial is expected to be a landmark clinical trial and is the first of its kind, enrolling a total of 946 subjects. Dr Guy Chamberland, Tetra's Chief Scientific Officer (CSO) commented that: "a GMP certification from Health Canada's drug inspectorate is welcome as this certification will signal to the company that its manufacturing partners comply with GMP requirements for drug approval and increases the measures put in place to ensure patients' safety."
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