Optimi Health Announces Phase 3 Trial for MDMA-Assisted Therapy

We are a Canadian Good Manufacturing Practices (“GMP”) compliant, pharmaceutical drug manufacturer licensed by Health Canada for the handling of controlled substances and GMP production. We specialize in controlled substances with our products being 3,4-Methylenedioxymethamphetamine hydrochloride (“MDMA”) and psilocybin derived from botanical sources. With a vertically integrated approach, we own two approximately 10,000-square-foot production facilities on leased land in Princeton, British Columbia and operate under a Drug Establishment Licence (“DEL”) awarded by Health Canada. Our DEL certifies that our facilities and quality management systems comply with GMP for the formulation of designated drug products and the manufacture of certain active pharmaceutical ingredients (“API”) from plant sources. Additionally, we hold a Dealer’s Licence (“DL”) under Canada’s Narcotic Control Regulations, allowing us to possess, produce, assemble, sell, and deliver psilocybin and other psychedelic substances within the regulated framework set forth by Health Canada. The DL allows us to possess up to 20kg of psilocybin and 200g of psilocin (equivalent to approximately 2,000kg of dried full-body psilocybin-containing mushrooms) and 2kg of MDMA. We also hold a Precursor Licence under Canada’s Precursor Regulations allowing us to import 3,4-Methylenedioxyphenyl-2-Propanone if used in the synthesis of MDMA.