Tag: Dealer’s License

Optimi Health Provides Dealer License Update and Comments on Health Canada’s Amendments to the Special Access Program (SAP)

SAP amendment allows practitioners to request access to psychedelic drugs for patients with serious or life-threatening conditions on a case-by-case basis.

VANCOUVER, BC ( January 5, 2022) — Optimi Health Corp. (CSE: OPTI) (OTCQB: OPTHF) (FRA: 8BN) (“Optimi” or the “Company”), developers of a vertically integrated mushroom brand targeting functional and novel psychedelic compounds for the health and wellness sector, is pleased to report the successful completion of the Health Canada inspection on December 21, 2021. The Company is in close contact with the regulator and welcomes finalization of the process in the coming weeks. Additionally, Optimi commends Health Canada for taking an active leadership role in finding solutions for the ongoing Canadian mental health crisis including access to psilocybin for therapeutic purposes through the Special Access Program (SAP).

Background

In Canada, drugs are authorized for sale only once they have successfully gone through the drug review process, including evaluation of safety, effectiveness and quality. However, Health Canada’s SAP allows practitioners to request access to drugs that are not available in Canada for the emergency treatment of patients with serious or life-threatening conditions who have exhausted other treatment options. Due to regulatory changes made in 2013, restricted drugs have not been made available through the SAP.

Since then, clinical trials have been the only avenue by which the sale of a restricted drug could be authorized for patient treatment. While clinical trials remain the best mechanism to authorize the sale of drugs, there are barriers to patient participation including geography or lack of clinical trial recruitment.

Yet, there has been ongoing scientific research into the efficacy and safety of certain restricted drugs. In response, Health Canada has today announced a reversal of the regulatory changes made in 2013 to Part C of the Food and Drug Regulations and has restored potential access to restricted drugs through the SAP.

What the regulatory amendments mean for Canadians

The regulatory amendments will allow physicians to request patient access to psychoactive substances, like psilocybin and MDMA, for psychedelic-assisted therapy. Decisions will remain on a case-by-case basis and will be reserved for serious, treatment-resistant or life-threatening conditions. The amendments have the potential to positively affect the lives of people experiencing serious mental health conditions and end-of-life distress when other therapies have failed, are unsuitable or are unavailable in Canada.

“Optimi acknowledges the Trudeau government, former Health Minister Patty Hajdu, current Health Minister, Jean-Yves Duclos, Minister of Mental Health and Addictions, Carolyn Bennett, and officials within Health Canada’s Legislative and Regulatory Affairs Department for giving the public an opportunity to consult on this important program,” notes Bill Ciprick, Optimi’s CEO. “We believe the amendments will bring much-needed relief and comfort to the hundreds of veterans, first-responders and Canadians who will immediately benefit from psychedelic psychotherapy to help with treatment-resistant depression that is considered serious and life-threatening by their physician.”

Our vision

Upon approval of the Dealer’s license, Optimi’s vision is to be the leader in providing safe supply and the highest-grade GMP certified psilocybin across Canada and the world. We agree with Health Canada there should be continued research to test the efficacy and safety of  psychedelic drugs. Our first clinical trial to determine the safe and effective standardized micro-dose of psilocybin for mental health including anxiety and depression is currently awaiting Health Canada approval. Earlier last year, Optimi received a Section 56 exemption for research purposes and this initial trial will be conducted at the Bloom Clinic, which is Calgary’s first psychedelic assisted therapy centre.

“Optimi is committed to the safety and efficacy of our product, and we look forward to supplying Canadian and global institutions with the highest-quality psilocybin in the market,” said Mr. Ciprick.

The Company also announces it has issued 50,000 common shares, at a deemed price of $0.465 per share, subject to a hold period expiring May 5, 2022, in consideration of services provided.

On Behalf of the Board of Directors,

Bill Ciprick
Chief Executive Officer
Optimi Health Corp.

ABOUT OPTIMI (CSE: OPTI) (OTCQB: OPTHF) (FRA: 8BN)

Optimi is developing a sophisticated mushroom brand that focuses on the health and wellness markets. With a vertically integrated approach, Optimi intends to cultivate, extract, process and distribute high quality functional mushroom products at its two facilities comprising a total of 20,000 square feet nearing completion in Princeton, British Columbia. To fully investigate the science of mushrooms, the Company has received a research exemption under Health Canada Food and Drug Regulations (FDR) for the use of Psilocybin and Psilocin for scientific purposes via its wholly owned subsidiary Optimi Labs Inc. Optimi has also applied for a dealer’s license under Canada’s Narcotic Control Regulations governing possession, distribution, sale, laboratory analysis of and research and development of Psilocybin and Psilocin formulations. Optimi is committed to expert cultivation and quality production subject to and in accordance with the terms of all applicable laws and governing regulations to ensure safe, superior Canadian fungi production. Find out more at: https://optimihealth.ca/.

FOR FURTHER INFORMATION CONTACT:

Investor Relations
Email: investors@optimihealth.ca
Phone: +1 (778) 930-1321
Web: https://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 the Company’s potential Nasdaq listing, the dealer’s license application, activities proposed to be conducted under the Company’s research exemption and associated business related to Psilocybin and Psilocin 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 Final Prospectus dated February 12, 2021. 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.

The CSE does not accept responsibility for the adequacy or accuracy of this release.

Optimi Health Receives Dealers License Inspection and Introduces Quality Assurance Department

VANCOUVER, BC (December 21, 2021) — Optimi Health Corp. (CSE: OPTI) (OTCQB: OPTHF) (FRA: 8BN) (“Optimi” or the “Company”), developers of a vertically integrated mushroom brand targeting functional as well as novel psychedelic compounds focused on the health and wellness sector, is pleased to announce a facility inspection under the auspices of Health Canada has commenced concurrent with today’s announcement regarding the implementation and inauguration of an internal control department focused on Quality Assurance efforts aimed at ensuring GMP standards are fully integrated and maintained at all times, post facility certification and commissioning.

As previously noted (news release Dec 7, 2021), the Princeton, BC mushroom facility has been purpose-built to meet globally recognized GMP standards as part of the Company’s aim to develop a world-class seed-to-sale research and commercial production facility designed to compete at the very highest level of product excellence.

Since December of 2020, the Company has invested over CAD$8.5 million in completing its state-of-the-art facilities in full compliance with Health Canada’s Directives and all regional, provincial, and federal security, design and building standards. Optimi believes that the completion of the physical inspection by Health Canada, subject to any comments or concerns, paves the way for Dealers License certification early in the new year.

Alongside the installation of operational and laboratory research equipment and final exterior fittings, the Company is rapidly moving towards an operational posture including the commencement of human resource plans for phase one departmental activation. The first additions to the operations team comes with today’s announcement introducing the buildout of Optimi’s Quality Assurance department with the appointment of Department Head, Mr. Raphael Moxam and QA Manager, Farkhanda Saifullah Khowaja, Ph.D.

Quality Assurance in a controlled growing environment requires extensive knowledge of specialized agronomy as well as operational considerations such as (but not limited to), environmental considerations and monitoring systems (i.e.: ventilation, humidity), fertilizer, nutrient composition, product care & handling, facility cleanliness, pest control, irrigation, and related systems. The department will oversee both quality control (QC) and quality assurance (QA) and compliance with Health Canada’s QA guidelines pertaining to business, production, facility, security, storage, packaging, labeling as well as establishing and enforcing GAP, GMP, HACCP standards for the Mushroom program. The team will develop, update, audit and maintain Standard Operating Procedures (SOP) and Quality Manuals ensuring continuous compliance with regulations and our own commitment to pure, high-quality products.

The Company’s goal and ambition towards becoming the leading producer and supplier of GMP certified medicinal and psychedelic mushrooms strains starts with Quality Assurance and Mr Moxam and Ms. Khowaja have the necessary expertise to execute. Mr. Moxam previously served as the Senior Quality Assurance Officer at DSM-Dietary Nutritional Products (DNP) and Process Chemist II (Pharmaceutical-cGMP) at Apotex Pharmachem Inc. During this period, he worked as liaison with government regulatory bodies, and implemented safety and quality standards for products. In these roles, he was responsible for developing equipment qualification, process validation, Quality Systems including SOP, recall procedures, HACCPs, and quality assurance of raw materials and products, for pharmaceutical drugs and fish oil products. He is experienced in the development of effective preventative actions, optimizing production processes to decrease the chance of out-of-specifications conditions, trouble shoot out-of-specifications and production equipment monitoring failures, and reviewed and/or approved laboratory equipment qualifications and validated analytical test methods. Mr Moxam earned his B.Sc. Chemistry at McMaster University, Hamilton, Ontario.

Ms. Khowaja previously served over 5 years at a Cannabis Cultivation Facility utilizing environmentally controlled automated systems with credentials approved by Health Canada for Quality Assurance Person (worked as Independent Contractor for responsibilities of QC/QA Supervisor, Production Manager, and leading R&D related activities). She gained hands-on knowledge of BioTrackTHC software, this comes under the category of ERP system for operational and business activities and keeping complete and auditable batch records from seed to sale. Ms. Khowaja has the proven ability to obtain security clearances. Ms. Khowaja earned her Ph.D. in Plant Molecular Genetics at the University of Aberdeen, U.K., M.Sc. in Plant Biotechnology, Wye College, University of London, U.K. and B.Sc. in Plant Breeding, Sindh Agriculture University, Tando Jam, Pakistan.

Optimi COO Bryan Safarik notes, “As we near facility completion and certification, the activity level on-site is shifting dramatically from construction to detailed preparations for commercial efforts to commence. To say it is exciting is such an understatement. Years of effort, millions of dollars and so much planning are materializing before our eyes. Even so, the real work is just about to begin. With this shift comes new attention to processes, procedures and policies that will form the basis for our future success. I’m delighted to have the opportunity to introduce our new Quality Assurance department and can’t wait to get started working with Raphael and Farkhanda. Their experience and attention to detail is developmentally critical to our ability to deliver the highest quality products in our sector. This is of extreme importance to us as we are 100% committed to delivering the finest all-natural products to our future customers.”

On Behalf of the Board of Directors,

Bill Ciprick
Chief Executive Officer
Optimi Health Corp.

ABOUT OPTIMI (CSE: OPTI) (OTCQB: OPTHF) (FRA: 8BN)

Optimi is developing a sophisticated mushroom brand that focuses on the health and wellness markets. With a vertically integrated approach, Optimi intends to cultivate, extract, process and distribute high quality functional mushroom products at its two facilities comprising a total of 20,000 square feet nearing completion in Princeton, British Columbia. To fully investigate the science of mushrooms, the Company has received a research exemption under Health Canada Food and Drug Regulations (FDR) for the use of Psilocybin and Psilocin for scientific purposes via its wholly owned subsidiary Optimi Labs Inc. Optimi has also applied for a dealer’s license under Canada’s Narcotic Control Regulations governing possession, distribution, sale, laboratory analysis of and research and development of Psilocybin and Psilocin formulations. Optimi is committed to expert cultivation and quality production subject to and in accordance with the terms of all applicable laws and governing regulations to ensure safe, superior Canadian fungi production. Find out more at: https://optimihealth.ca/.

FOR FURTHER INFORMATION CONTACT:

Investor Relations
Email: investors@optimihealth.ca
Phone: +1 (778) 930-1321
Web: https://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 the Company’s potential Nasdaq listing, the dealer’s license application, activities proposed to be conducted under the Company’s research exemption and associated business related to Psilocybin and Psilocin 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 Final Prospectus dated February 12, 2021. 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.

The CSE does not accept responsibility for the adequacy or accuracy of this release.

Optimi Health Requests Final Inspection for Dealer’s License

VANCOUVER, BC (December 7, 2021) — Optimi Health Corp. (CSE: OPTI) (OTCQB: OPTHF) (FRA: 8BN) (“Optimi” or the “Company”), developers of a vertically integrated mushroom brand targeting functional as well as novel psychedelic compounds focused on the health and wellness sector, is pleased to announce it has substantially completed construction on its proposed Dealer’s License facility in Princeton, British Columbia and called for final site inspection.

The Optimi team has relentlessly endeavored to build world-class GMP capable facilities from the ground up. Since December of 2020, the Company has been heavily invested in completing its state-of-the-art facilities in full compliance with Health Canada’s Directive on Physical Security Requirements for Controlled Substances. As noted in the recently filed annual financials, as of September 30, 2021, $8,586,465 CAD of expenditures was incurred in connection with the construction of these facilities. Following on the Company’s facility update September 14, 2021, the schedule 8 security protocol is commissioned, Argus environmental control system is being installed, curbs and blacktop poured, interior clean walls are erect, HVAC units are mounted, and ancillary cultivation equipment has arrived on site.

Concurrent to the finalization of the dealer’s license submission the Company has now presented its analytical laboratory license for consideration and review. Optimi believes a healthy domestic regulatory environment is a critical and necessary driver of the rigorous safety and security regulations for licensed producers and builds confidence in local production quality and capacity. By adhering to Health Canada guidelines in the development of facilities and practices, Optimi believes it is positioned to exceed initial internal expectations for product excellence and delivery.

“Regulations are critical and necessary for building product safety and efficacy,” notes Company CSO Justin Kirkland. “With the tools we now have available, we are highly confident in our ability to isolate high purity natural psilocybin from our own mushroom harvest. We are looking forward to working with Health Canada, and other global regulatory agencies in order to deliver the finest all-natural products wherever possible.”

The Company has recently completed the purchase of research and development as well as analytical instrumentation which is poised to dramatically ramp up in-house productivity. Upon final approval by the onsite quality assurance team, Optimi will be able to provide assays to include potency testing by high-performance liquid chromatography including a diode array detector that allows for measuring multiple substance at multiple wavelengths (or components) simultaneously. Additional study capability includes potency, stability and identity testing utilizing thin layer chromatography, ultraviolet-visible spectroscopy, and mass spectrometry. The laboratory now provides an advanced ability to test for heavy metals and elemental impurities in compliance with guidelines put forth by the FDA, USP and ICH organizations to protect patients from the risks associated with heavy metal contaminants.

Michael Kydd, regulatory consultant to Optimi states, “The Company is clearly focused on respecting the regulatory process and by so doing, is positioning itself as an undisputed global supply leader through the development of one of Canada’s highest-quality GMP-capable facilities. The entire team looks forward to building strong relationships within national and international governments as the industry matures. In my opinion collaboration and communication define excellence, and the work we undertake today with Health Canada positions us to propel Optimi as an industry leader in standards and excellence around the world.”

Optimi Health CEO Bill Ciprick concludes, “I’m extremely proud of our recent and ongoing achievements. The senior leadership team has a strong history of operational and facility management in the cultivation of GMP-certified health products. That experience took time to build, and it now places Optimi Health in contention as a potential North American leader in the production of functional and medicinal mushrooms. Our common outlook is predicated on working together to optimize human development and fundamentally improve the physical, spiritual, and mental well-being of those impacted by serious mental health problems. It is potentially a massive sector, and with all that is going on around the world today, the need for improved health and wellness solutions has never been greater. Once again, our heartfelt thanks for the continued assistance of all our supporters as we grow this exciting and timely enterprise.”

On Behalf of the Board of Directors,

Bill Ciprick
Chief Executive Officer
Optimi Health Corp.

ABOUT OPTIMI (CSE: OPTI) (OTCQB: OPTHF) (FRA: 8BN)

Optimi is developing a sophisticated mushroom brand that focuses on the health and wellness markets. With a vertically integrated approach, Optimi intends to cultivate, extract, process and distribute high quality functional mushroom products at its two facilities comprising a total of 20,000 square feet nearing completion in Princeton, British Columbia. To fully investigate the science of mushrooms, the Company has received a research exemption under Health Canada Food and Drug Regulations (FDR) for the use of Psilocybin and Psilocin for scientific purposes via its wholly owned subsidiary Optimi Labs Inc. Optimi has also applied for a dealer’s license under Canada’s Narcotic Control Regulations governing possession, distribution, sale, laboratory analysis of and research and development of Psilocybin and Psilocin formulations. Optimi is committed to expert cultivation and quality production subject to and in accordance with the terms of all applicable laws and governing regulations to ensure safe, superior Canadian fungi production. Find out more at: https://optimihealth.ca/.

FOR FURTHER INFORMATION CONTACT:

Investor Relations
Email: investors@optimihealth.ca
Phone: +1 (778) 930-1321
Web: https://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 the Company’s potential Nasdaq listing, the dealer’s license application, activities proposed to be conducted under the Company’s research exemption and associated business related to Psilocybin and Psilocin 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 Final Prospectus dated February 12, 2021. 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.

The CSE does not accept responsibility for the adequacy or accuracy of this release.