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Optimi Health Corp. ( CSE: OPTI ) (OTCQX: OPTHF) (FRA: 8BN) ("Optimi" or the "Company"), a Canadian-based company licensed by Health Canada to produce natural, scalable, and accessible psychedelic and functional mushrooms for transformational human experiences, has received permission from Health Canada to manufacture and distribute additional psychedelic substances, most notably MDMA, under the amended terms outlined in its June 20, 2022 application to Health Canada.
Under the leadership of Chief Science Officer Justin Kirkland, Optimi will now act as wholesale supplier of MDMA and other synthetic psychedelic compounds to approved researchers and drug developers.
The Company is scheduled to begin production and analytical testing of MDMA this October in its recently completed EU-GMP pharmaceutical manufacturing facility.
Optimi CEO, Bill Ciprick, says the Company's in-house capacity to produce a wide range of scalable formulations puts Optimi at the forefront of the commercial manufacturing and supply of psychedelics.
"From lab to market, Optimi has taken every step necessary to build its competitive position as a global leader in the manufacturing of EU-GMP compliant MDMA in North America, and we've done that through operational transparency and investing in smart infrastructure."
He further added, "On compliance, quality, and scale, we have consistently demonstrated our plan to lead the industry in API synthesis and formulation, which gives our science and operations team the confidence to develop saleable psychedelic products that are supported by rigorous in-house Standard Operating Procedures (SOP)," said Ciprick.
The terms of the amendment took effect as of Friday, August 5, 2022, and will allow the Company to increase the overall output potential of its Princeton, British Columbia facility to better address the needs of the evolving psychedelic market as part of Optimi's planned year of commercialization.
Since applying for the amendment in June, the Company has met with industry stakeholders, drug developers, and clinical trial researchers interested in exploring Optimi's production capabilities, reaffirming the Company's decision to proceed with this phase of its commercialization strategy.
Regulatory Opportunity
In May 2022 it was reported by online publication, The Intercept , that the Joe Biden administration was anticipating FDA regulation of MDMA and psilocybin within the next two years and was "exploring the prospect of establishing a federal task force" to review the psychedelic ecosystem.
With 130 MDMA clinical trials currently listed between Canada and United States , and the prospect of the Biden Administration looking to regulate MDMA and psilocybin, Optimi is already preparing for future international and domestic regulatory movement that could positively impact the Company.
"The regulatory landscape in the U.S and Canada is always evolving, specifically with the Canadian government's recent decision to decriminalize MDMA up to 2.5 grams in British Columbia," said Optimi regulatory affairs advisor, Michael Kydd. "Governments often use incremental shifts in policy to test public sentiment, which sometimes triggers broader policy change down the road. Having a licence to produce EU-GMP MDMA at an unmatched scale will benefit the Company when we eventually see these wholesale policy changes," added Kydd.
On August 10, Optimi unveiled Blue Serenity Natural Psilocybin in collaboration with renowned psilocybin advocate, Thomas Hartle. The product is now available to patients who face a serious or life-threatening condition and have been approved under Canada's Special Access Program.
In addition to MDMA, the Company now has Health Canada approval to manufacture and distribute additional substances including:
N,N-Dimethyltryptamine ("DMT");
3,4,5-trimethoxyphenethylamine ("Mescaline");
2-(2-chlorophenyl)-2- (methylamino)cyclohexanone ("Ketamine");
Lysergic Acid Diethylamide ("LSD");
1-(1-phenylcyclohexyl)piperidine ("Phencyclidine");
4-Hydroxybutanoic Acid ("GHB");
4,9–dihydro–7–methoxy–1–methyl–3H–pyrido(3,4–b)indole ("Harmaline");
4,9–dihydro–1–methyl–3H–pyrido(3,4–b)indol–7–ol ("Harmalol");
Salvia Divinorum, Salvinorin A; and,
4-Bromo-2,5-Dimethoxybenzeneethanamine ("2C-B").
Authorized parties interested in purchasing Optimi psilocybin and functional mushroom products, MDMA, or other additional psychedelics are invited to contact sales@optimihealth.ca where a member of the sales team will respond within 24 hours.
ABOUT OPTIMI (CSE: OPTI) (OTCQX: OPTHF) (FRA: 8BN)
Optimi Health Corp. is a Canadian-based company licensed by Health Canada to produce and supply natural, EU-GMP grade psilocybin and synthetic psychedelic substances, as well as functional mushrooms that focus on the health and wellness markets. Built with the purpose of producing scalable psychedelic formulations for transformational human experiences, the Company's goal is to be the number one trusted, compassionate supplier of safe drug products throughout the world. Optimi's products are grown at its two facilities comprising a total of 20,000 square feet in Princeton, British Columbia, making it the largest psilocybin and MDMA cultivator in North America.
FOR INTERVIEW REQUESTS OR FURTHER INFORMATION PLEASE CONTACT:
Investor Relations
Michael Kydd
Email: investors@optimihealth.ca
Phone: +1 (902) 880 6121
www.optimihealth.ca
FORWARD‐LOOKING STATEMENTS
This news release contains forward‐looking statements and forward‐looking information within the meaning of Canadian securities legislation (collectively, "forward‐looking statements") that relate to Optimi's current expectations and views of future events. Any statements that express, or involve discussions as to, expectations, beliefs, plans, objectives, assumptions or future events or performance (often, but not always, through the use of words or phrases such as "will likely result," "are expected to," "expects," "will continue," "is anticipated," "anticipates," "believes," "estimated," "intends," "plans," "forecast," "projection," "strategy," "objective," and "outlook") are not historical facts and may be forward‐looking statements and may involve estimates, assumptions and uncertainties which could cause actual results or outcomes to differ materially from those expressed in such forward‐looking statements. No assurance can be given that these expectations will prove to be correct and such forward‐looking statements included in this news release should not be unduly relied upon. These statements speak only as of the date of this news release. In particular and without limitation, this news release contains forward‐looking statements pertaining to activities proposed to be conducted under the Company's dealer's licence and associated business related to Psilocybin, Psilocin, other psychedelic substances, and Optimi's plans, focus and objectives.
Forward‐looking statements are based on a number of assumptions and are subject to a number of risks and uncertainties, many of which are beyond Optimi's control, which could cause actual results and events to differ materially from those that are disclosed in or implied by such forward‐looking statements. Such risks and uncertainties include, but are not limited to, the impact and progression of the COVID‐19 pandemic and other factors set forth under "Forward‐Looking Statements" and "Risk Factors" in the Company's Annual information Form dated January 12, 2022, and other continuous disclosure filings available under Optimi's profile at www.sedar.com. Optimi undertakes no obligation to update or revise any forward‐looking statements, whether as a result of new information, future events or otherwise, except as may be required by law. New factors emerge from time to time, and it is not possible for Optimi to predict all of them or assess the impact of each such factor or the extent to which any factor, or combination of factors, may cause results to differ materially from those contained in any forward‐looking statement.
Any forward‐looking statements contained in this news release are expressly qualified in their entirety by this cautionary statement.
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