BIDEN ADMINISTRATION PLANS FOR LEGAL PSYCHEDELIC THERAPIES WITHIN TWO YEARS

A letter from the Health and Human Services Department discloses the anticipated FDA approval of MDMA and psilocybin treatments.

In something of a bolt from the blue, Mattha Busby of The Intercept shared the groundbreaking news from Washington D.C. on Tuesday, July 26, that the Biden Administration is preparing for the reality of FDA approval for psychedelic-assisted therapies involving MDMA and psilocybin.

From the article:

“As twin mental health and drug misuse crises kill thousands of people per week, the potential of psychedelic-assisted therapies “must be explored,” urges a federal letter on behalf of the U.S. health secretary and shared with The Intercept. President Joe Biden’s administration “anticipates” that regulators will approve MDMA and psilocybin within the next two years for designated breakthrough therapies for PTSD and depression respectively. The administration is “exploring the prospect of establishing a federal task force to monitor” the emerging psychedelic treatment ecosystem, according to the letter sent by assistant secretary for mental health and substance use Miriam Delphin-Rittmon to Rep. Madeleine Dean, D-Pa. The May correspondence, not shared publicly until now, is the clearest indication yet that top officials are preparing for the approval of psychedelic drugs — demonized for decades after former President Richard Nixon sought means to attack the anti-Vietnam War counterculture in the late 60s which was arguably unthinkable even five years.

This represents a seismic shift in policy, which Optimi Health sincerely hopes that the Canadian government will reciprocate.

It is also an immense moral victory for researchers, activists and policy reformers who have been slowly but surely championing the power of these substances through decades of prohibition that such an approval would signify.

But we aren’t there yet.

There is still work to be done, clinical trials to be completed, and a safe supply of EU-GMP psilocybin and MDMA to be shored up in order to ensure that this promise becomes a reality.

ABOUT OPTIMI

(CSE: OPTI) (OTCQX: OPTHF) (FRA: 8BN)

FOR INTERVIEW REQUESTS OR FURTHER INFORMATION PLEASE CONTACT:

Investor Relations
Email: investors@optimihealth.ca
Phone: +1 (902) 880 6121
Web: www.optimihealth.ca

Optimi Health Corp. is an end-to-end Canadian-based drug manufacturer and formulator licensed by Health Canada to produce and supply psychedelic substances such as 3,4-Methylenedioxymethamphetamine (“MDMA”) and GMP-grade psilocybin, 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 and manufactured at its two facilities comprising a total of 20,000 square feet in Princeton, British Columbia, making it the largest psilocybin and MDMA producer in North America.

Operational Strength:

• Optimi is producing GMP psilocybin — as well as OPTI-MHCL using Optimi’s scalable, proprietary production method — in-house under the terms of its Health Canada issued Dealers Licence.

• Optimi is also manufacturing MDMA and psilocybin under GMP-compliant protocols, making additional products available for clinical research, drug development, and therapist training initiatives.

• OPTI-MHCL was tested for purity on-site with a result of >99% which the Company is validating through a third-party laboratory.

FOR INTERVIEW REQUESTS OR FURTHER INFORMATION PLEASE CONTACT:

Investor Relations
Email: investors@optimihealth.ca
Phone: +1 (902) 880 6121
Web: 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 approved Health Canada dealer’s licence and associated business related to Psilocybin, Psilocin, other psychedelic substances, some being synthetically formulated, 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 9, 2023, 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.

Products do not contain psilocybin

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