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Optimi Health Corp. (OPTHF) is a leading Health Canada-licensed psychedelics pharmaceutical manufacturer, specializing in controlled substances such as botanical psilocybin and MDMA. The company recently obtained a Drug Establishment Licence (DEL) from Health Canada, confirming compliance with Good Manufacturing Practices (GMP). This allows Optimi to supply MDMA and psilocybin capsules to patients with PTSD and Treatment-Resistant Depression under Australia's Authorized Prescriber Scheme and export to regulated jurisdictions globally. Optimi aims to be the trusted global supplier of safe drug candidates by producing proprietary formulations in its 20,000 square feet facilities in Princeton, BC.
Optimi Health Corp. (OTCQX: OPTHF) has announced a significant long-term distribution agreement with Mind Medicine Australia to supply GMP-grade MDMA and psilocybin for therapeutic use in Australia. This follows the Australian government's reclassification allowing authorized psychiatrists to prescribe these substances for treatment-resistant conditions starting July 1, 2023. Key aspects include signed purchase orders for medical-grade substances manufactured under GMP protocols at Optimi's Health Canada licensed facility. This agreement represents Optimi's first international sales of these products, supporting the push for expanded access to psychedelic therapies in response to the mental health crisis.
Optimi Health Corp. has submitted a clinical trial application for a Phase I study to evaluate the safety of its natural psilocybin standardized extract and proprietary MDMA drug candidate in healthy therapists. This trial, conducted in collaboration with ATMA Journey Centers, is the first to compare the effects of both substances. The study aims to enroll 25 participants across five groups, assessing safety and physiological markers. The company aims to address the significant shortage of therapists trained in psychedelic therapy as it progresses towards commercialization.
Optimi Health Corp. has announced the successful production of its proprietary MDMA drug candidate, OPTI-MHCL, under Good Manufacturing Practices (GMP) at its facility in Princeton, British Columbia. The drug, which demonstrates a purity of over 99%, is intended for clinical trials and patient access through Health Canada’s Special Access Program and Australia’s Authorized Prescriber Scheme.
Optimi aims to meet the growing global demand for MDMA, particularly with advancements towards FDA approval for MDMA-assisted therapy for PTSD. This end-to-end manufacturing process positions Optimi as a significant supplier in the psychedelics market.
Optimi Health Corp (OTCQX: OPTHF) announced a significant expansion of its sales network in Canada on January 17, 2023. The company, licensed by Health Canada, produces natural psilocybin and functional mushrooms. Key partnerships have been formed with Purity Life Health Products for distribution and M2 Brand Management as the exclusive retail broker to increase brand presence. Products will be sold online via Amazon.ca and at six Holt Renfrew locations by February 2023. The CEO has emphasized that this expansion is a critical part of their revenue strategy moving forward.
Optimi Health Corp. announces the re-election of five board members following its Annual General Meeting on January 9, 2023. The directors re-elected include Bryan Safarik, Jacob Safarik, Jon Schintler, Dane Stevens, and JJ Wilson. The company also expressed gratitude to outgoing director Michael Stier. Additionally, Smythe LLP was re-appointed as the auditor, and the Company’s Equity Incentive Plan was re-approved. Optimi operates under Health Canada regulations, focusing on natural and synthetic psychedelic substances and functional mushrooms for the wellness market.
Optimi Health applauds Alberta's decision to regulate psychedelics for therapeutic use, highlighting the importance of a safe supply of psilocybin and MDMA for mental health treatment. Effective January 16, 2023, physicians will be able to prescribe these substances for treatment-resistant conditions. As the largest cultivator of EU-GMP psilocybin and MDMA in North America, Optimi is strategically positioned to support the province's new framework. The company's CEO describes this regulatory move as politically courageous, reaffirming the clinical benefits of psychedelics in addressing mental health challenges.
Optimi Health Corp (OTCQX: OPTHF) announced plans to initiate a Phase I clinical trial in collaboration with ATMA Journey Centers to assess the safety of its natural psilocybin and MDMA formulations in healthy subjects. This trial, pending Health Canada's approval, aims to gather critical health data including blood pressure and heart rate, marking a significant milestone towards commercialization. Following ATMA's previous trial success, Optimi's CEO expressed confidence in the demand for these therapies among healthcare professionals, who are awaiting effective psychedelic solutions.
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