Health Canada – MJ Shareholders https://mjshareholders.com The Ultimate Marijuana Business Directory Wed, 17 Aug 2022 16:48:30 +0000 en-US hourly 1 https://wordpress.org/?v=6.5.3 Adastra Expands Market Footprint Through Receipt of Medical Sales License from Health Canada https://mjshareholders.com/adastra-expands-market-footprint-through-receipt-of-medical-sales-license-from-health-canada/ Wed, 17 Aug 2022 16:48:30 +0000 https://www.cannabisfn.com/?p=2958941

Ryan Allway

August 17th, 2022

News, Top News


LANGLEY, BC / ACCESSWIRE / August 17, 2022 / Adastra Holdings Ltd. (CSE:XTRX)(FRA:D2EP) (“Adastra” or the “Company”), a leading cannabis company focused on processing, product development, sales, organoleptic testing and analytical testing, is pleased to announce it has received its Medical Sales License from Health Canada which now authorizes Adastra to sell cannabinoid-containing products that are formulated for and distributed to the medical cannabis market.

With its Medical Sales License, Adastra is now authorized to:

  • Sell cannabis extracts and dried cannabis to medical cannabis patients and licensed health practitioners; and
  • Develop a broad range of products classified as cannabis extracts including:
    • Inhaled (vaporizer cartridge and shatter),
    • Ingested (tincture, oil, capsule, soft gel and oral spray), and
    • Other (suppository).

“This license marks another milestone for Adastra as we see a significant market opportunity for plant-based, natural medical remedies,” said Michael Forbes, Chief Executive Officer of Adastra. “We are excited to now produce and distribute cannabis product formats, designed for the medical market as Canada once again re-forms this patient-focused market that was the foundation for federal legalization. With my background in healthcare and strong ties to the medical community – including some of Canada’s largest pharmacy distributors and pharmacies – Adastra’s ability to produce and sell to the re-emerging and established medical market positions us to leverage our PerceiveMD clinics for direct-to-patient sales and pharmacy sales. Adastra has the added advantage through our PerceiveMD clinics to work directly with medical patients and collaborate with practitioners in developing plant-based alternative remedies designed for the medical cannabis market.”

Adastra’s Medical Sales License will enable the Company to maximize the full potential of PerceiveMD, Adastra’s wholly-owned platform, that assesses patients seeking alternative treatments and remedies and provides documentation to enable access.

“We continue to see an uptick in the therapeutic use of cannabis for symptom relief – everything from cancer, menopause, stress, depression, anxiety and so on,” Forbes added. “There is less stigma and more awareness today than ever before about the potential healing and symptom relief qualities of cannabis. We believe we’ll continue to see a rise in popularity of cannabis for medicinal purposes and we are positioning Adastra to capture and serve this significant market.”

The global medical cannabis market is projected to grow to $248.42 billion by 2030 at a 31.97% CAGR according to a recent report by Market Research Future. 1

Adastra expects to start producing medical format cannabis products, specifically CBD tinctures by January 2023. The Company is currently exploring medical distribution platforms for Canadian sales and plans to formulate products based on recommendations from practitioners and patients in its established network.

Note 1: https://ca.finance.yahoo.com/news/medical-marijuana-market-worth-usd-160000093.html

About Adastra Holdings Ltd.
Adastra is a leading manufacturer and supplier of innovative ethnobotanical and cannabis science products designed for the adult-use, medical markets and forward-looking therapeutic applications. Adastra is recognized as a high-capacity processor and co-manufacturer throughout Canada. Adastra acquired 100% of the legacy-built brand Phyto Extractions in September 2021. The brand is well-known for its cannabis concentrate products, available on shelves at over 1,400 adult-use retailers across the country. The Company also operates Adastra Labs, a 13,500 sq. ft. agricultural-scale Health Canada licensed facility located in Langley, British Columbia, focused on extraction, distillation, and manufacturing of cannabis-derived products. Adastra has successfully taken steps in becoming a licensed cultivator, tester, extractor, and seller of controlled substances, including Psilocybin and Psilocin, by applying for a Controlled Substances Dealer’s License, which is under review by Health Canada. Pending Health Canada approval, Adastra is poised to be a drug formulation and development leader in this emerging sector. In addition, the acquisition of 1225140 B.C. Ltd., doing business as PerceiveMD, Adastra operates a multidisciplinary manufacturer for medical cannabis and psychedelic therapies, working alongside practitioners and healthcare professionals within the regulated environment to help create efficacious remedies that address the actual needs of patients. For more information, visit: www.adastraholdings.ca.

Contacts
Michael Forbes, CEO, Corporate Secretary & Director
(778) 715 5011,
[email protected]

Stephanie Martens, Investor Relations
[email protected]

Forward-Looking Information

This news release contains forward-looking information within the meaning of Canadian securities legislation concerning the business of the Company. Forward-looking information is based on certain key expectations and assumptions made by the management of the Company. Although the Company believes that the expectations and assumptions on which such forward looking information is based are reasonable, undue reliance should not be placed on the forward-looking information because the Company can give no assurance that they will prove to be correct. Forward looking information in this news release includes statements regarding, but not limited to: (i) the expected activities that the Company may conduct with a Medical Sales License; (ii) the ability of the Company to leverage its existing clinics for direct-to-patient and pharmacy sales through its ability to sell to the growing and established medical market; (iii) the expectation that the Company will start producing medical cannabis products by January 2023; and (iv) pending approvals, Adastra is poised to be a drug formulation and development leader in controlled substances. There are numerous risks and uncertainties that could cause actual results and the Company’s plans and objectives to differ materially from those expressed in the forward-looking information. Important factors that could cause actual results to differ materially from those expressed in the forward-looking information include: the availability of a qualified workforce; changes in regulations or licensing affecting the Company’s business; reduced demand for cannabis and cannabis related products; reductions in the Company’s retail space and store locations; and other factors beyond the control of the Company. These and all subsequent written and oral forward-looking information are based on estimates and opinions of management on the dates they are made and are expressly qualified in their entirety by this notice. Except as required by law, the Company does not intend to update these forward-looking statements.

Adastra Holdings Ltd., Wednesday, August 17, 2022, Press release picture
Adastra Holdings Ltd., Wednesday, August 17, 2022, Press release picture

SOURCE: Adastra Holdings Ltd.

This article was published by CFN Enterprises Inc. (OTCQB: CNFN), owner and operator of CFN Media, the industry’s leading agency and digital financial media network dedicated to the burgeoning CBD and legal cannabis industries. Call +1 (833) 420-CNFN for more information.

About Ryan Allway

Mr. Allway has over a decade of experience in the financial markets as both a private investor and financial journalist. He has been actively involved in the cannabis industry since its inception, covering public and private companies.


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Health Canada Grants MDMA Production and Distribution Amendment to Optimi Health https://mjshareholders.com/health-canada-grants-mdma-production-and-distribution-amendment-to-optimi-health/ Tue, 16 Aug 2022 17:02:37 +0000 https://www.cannabisfn.com/?p=2958843

VANCOUVER, BC — 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 [email protected] 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.

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Luff Enterprises Announces Final Health Canada License Approval for the NG Biomed Group of Companies https://mjshareholders.com/luff-enterprises-announces-final-health-canada-license-approval-for-the-ng-biomed-group-of-companies/ Fri, 29 Jul 2022 21:32:30 +0000 https://www.cannabisfn.com/?p=2957023 About Luff Enterprises Ltd.

LUFF is a hemp and wellness company, focused on providing premium quality, innovative products across the United States through its online store.  Committed to plant-based science, LUFF produces and sources a suite of thoughtfully designed products to benefit a wide range of user needs.

Currently, the Company focuses on identifying unique products and formulations leveraging cannabinoids to empower people to realize the full potential of everyday life.  LUFF’s scientifically formulated products are non-GMO, THC-free, 3rd party tested, and only crafted with hemp grown in the United States.

THE CANADIAN SECURITIES EXCHANGE (THE “CSE”) HAS NEITHER APPROVED NOR DISAPPROVED THE CONTENTS OF THIS PRESS RELEASE. NEITHER THE CSE OR ITS MARKET REGULATOR (AS THAT TERM IS DEFINED IN THE POLICIES OF THE CSE) ACCEPTS RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE.

CAUTIONARY NOTE REGARDING FORWARD-LOOKING INFORMATION:
This news release may contain “forward-looking information” and “forward-looking statements” (collectively, “forward-looking statements”) within the meaning of the applicable Canadian securities legislation. All statements, other than statements of historical fact, are forward-looking statements and are based on expectations, estimates and projections as at the date of this news release. Any statement that involves discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, assumptions, future events or performance (often but not always using phrases such as “expects”, or “does not expect”, “is expected”, “anticipates” or “does not anticipate”, “plans”, “budget”, “scheduled”, “forecasts”, “estimates”, “believes” or “intends” or variations of such words and phrases or stating that certain actions, events or results “may” or “could”, “would”, “might” or “will” be taken to occur or be achieved) are not statements of historical fact and may be forward-looking statements. Forward-looking statements are necessarily based upon a number of estimates and assumptions that, while considered reasonable, are subject to known and unknown risks, uncertainties, and other factors which may cause the actual results and future events to differ materially from those expressed or implied by such forward-looking statements. Such factors include, but are not limited to general business, economic, competitive, political, and social uncertainties. There can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on the forward-looking statements and information contained in this news release. Except as required by law, Luff assumes no obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change, except as required by law.

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Zollaris Laboratories Corp. Receives Health Canada authorization to investigate PSILOCYBIN (PSYCHEDELIC MUSHROOMS) for potential new therapeutics https://mjshareholders.com/zollaris-laboratories-corp-receives-health-canada-authorization-to-investigate-psilocybin-psychedelic-mushrooms-for-potential-new-therapeutics/ Thu, 17 Feb 2022 04:40:13 +0000 https://www.cannabisfn.com/?p=2937917

Ryan Allway

February 16th, 2022

Psychedelics, Top News


Psilocybin therapy is being investigated by Zollaris for the treatment of mental health and other unmet medical needs

HAWKESBURY PROVIDENCEOntarioFeb. 16, 2022 /PRNewswire-PRWeb/ — Zollaris Laboratories Corporation. (hereafter, “Zollaris”) receives authorization from the Health Canada, Office of Controlled Substances for analytical investigation of several psilocybin powders currently permitted under license and available in Canada. The Health Canada license permits Zollaris to proceed to screen suitable candidates and drug preparations to be used in clinical trials to be initiated in 2022. Health Canada has recognized the importance of Zollaris’ analytical research infrastructure, drug development and manufacturing programs aimed at producing a molecular standardization of psilocybin form factors.

Psilocybin therapy is an approach being investigated for the treatment of mental health challenges where current drug therapies have known and unwanted adverse effects and present high potential to addiction. Psilocybin is a psychoactive ingredient found in some species of mushrooms, often referred to as “magic mushrooms” and which have been the focus of renewed interest for medical use in mental health where current therapeutics are not ideal. With this license, Zollaris can enter the pharmaceutical drug development arena to develop future therapeutics.

Under the title of “Drug Development Pathways to Bring Psilocybin (and Psilocin) to the Pharmaceutical Market”, Zollaris Labs will complete the necessary steps in order to produce the first standard of Psilocybin to be sold under USP certification.

Zollaris investigational program is a pivotal passage to get pharmaceutical grade Psilocybin powders with a Made in Canada stamp, in our fully licensed GMP Facility.

ABOUT ZOLLARIS

Zollaris Corporation is a 30,000 state-of-the-art facility located in Hawkesbury, ON. The facility was commissioned in 2019 and founded by experience pharmaceuticals leaders. Zollaris has several categories of licenses which enable it to contract manufacture, perform technical analysis of natural products (“NPNs”), cannabinoids and psychedelic’s for customers and its own brands to be sold in the appropriate medical and recreational channels.

Forward-looking statements

Some statements in this release may contain forward-looking information. All statements, other than statements of historical fact, that address activities, events or developments that the Company believes, expects or anticipates will or may occur in the future (including, without limitation, statements regarding potential acquisitions and financings) are forward-looking statements. Forward-looking statements are generally identifiable by the use of the words “may”, “will”, “should”, “continue”, “expect”, “anticipate”, “estimate”, “believe”, “intend”, “plan” or “project” or the negative of these words or other variations on these words or comparable terminology. Forward-looking statements are subject to a number of risks and uncertainties, many of which are beyond the Company’s ability to control or predict, that may cause the actual results of the Company to differ materially from those discussed in the forward-looking statements. Factors that could cause actual results or events to differ materially from current expectations include the Company’s inability to obtain sufficient financing to execute its business plan; competition; regulation; anticipated and unanticipated costs and delays; the success of the Company’s research and development strategies; the ability to obtain orphan drug status; the applicability of the discoveries made; the successful and timely completion and uncertainties related to the regulatory approval process; the timing of future clinical trials; the timing and outcomes of regulatory or intellectual property decisions; and other risks disclosed in the Company’s public disclosure record on file with the relevant regulatory authorities. Although the Company has attempted to identify important factors that could cause actual results or events to differ materially from those described in forward-looking statements, there may be other factors that cause results or events not to be as anticipated, estimated or intended. Readers should not place undue reliance on forward-looking statements. The forward-looking statements in this news release are made as of the date of this news release, and the Company does not undertake any obligation to publicly update them to reflect new information or subsequent events or otherwise except as required by applicable securities legislation.

Media Contact

Pascal Houde, Zollaris laboratories Corporation, 1 4168554545, [email protected]

SOURCE Zollaris laboratories Corporation

This article was published by CFN Enterprises Inc. (OTCQB: CNFN), owner and operator of CFN Media, the industry’s leading agency and digital financial media network dedicated to the burgeoning CBD and legal cannabis industries. Call +1 (833) 420-CNFN for more information.

About Ryan Allway

Mr. Allway has over a decade of experience in the financial markets as both a private investor and financial journalist. He has been actively involved in the cannabis industry since its inception, covering public and private companies.


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Optimi Health Approved to Supply Psilocybin Under Health Canada’s Special Access Program https://mjshareholders.com/optimi-health-approved-to-supply-psilocybin-under-health-canadas-special-access-program/ Wed, 16 Feb 2022 15:03:55 +0000 https://www.cannabisfn.com/?p=2937847

VANCOUVER, BC (GLOBE NEWSWIRE – February 16, 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 that Health Canada has added the Company’s wholly-owned subsidiary Optimi Labs Inc. to a list of approved suppliers under the Special Access Program (SAP). With a mission to provide compassionate, frontline solutions to Canada’s growing mental health crisis, the Company plans to supply psychedelics like psilocybin to those truly in need.

Announced on January 5, 2022, the SAP allows qualified medical practitioners to request access to Schedule 3 controlled substances such as psilocybin on a case-by-case emergency basis. Prior to the new regulatory amendments, medical practitioners were prohibited from requesting access to psilocybin and MDMA for individual psychedelic-assisted psychotherapy. 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’s CEO, Bill Ciprick, says the SAP is already having a positive impact on patients in need and will provide the Company with the right avenue to develop and supply the demand for natural psilocybin.

“Optimi is committed to bringing transformative change to those suffering from debilitating palliative and non-palliative mental health trauma,” said Ciprick. “We will leave no stone unturned in our effort to provide the safest and most efficacious natural psilocybin product in the world, because frankly we need to get this right for those depending on us for support and healing.”

“Between the science, research, and good manufacturing practices, the SAP is an excellent opportunity for all of us to learn, grow and expand our knowledge capacity and improve treatment outcomes for many people in the years to come,” added Ciprick.

With the Company’s Dealer’s License approved by Health Canada earlier this month, Optimi has received requests for supply agreements from potential partners interested in the Company’s new EU-GMP compliant 10,000 sq. ft. facility located in Princeton, British Columbia. Once fully commercialized, the production facility will position Optimi as a global frontrunner in the cultivation, extraction, and vertical integration of high-grade all-natural psilocybin.

“Establishing Optimi’s presence in the psychedelic market begins with trust, which we believe we have earned through our in-house expert research and world-class advisory team, and by setting the gold standard in GMP compliance,” added JJ Wilson, Optimi’s Chairman of the Board.

Optimi plans to host a grand opening of its new facility this May and is committed to building awareness and education about the benefits of the SAP to physicians qualified to recommend the program to patients.

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 and psychedelic 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 been granted 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: [email protected]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 activities proposed to be conducted under the Company’s dealer’s license 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 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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Filament Health Announces Health Canada Approval For Phase II Trial Administering New Psilocybin Microdose Formulation https://mjshareholders.com/filament-health-announces-health-canada-approval-for-phase-ii-trial-administering-new-psilocybin-microdose-formulation/ Wed, 05 Jan 2022 02:13:20 +0000 https://www.cannabisfn.com/?p=2936460

Ryan Allway

January 4th, 2022

Psychedelics


The clinical trial at the University of Toronto will study low doses of psilocybin in healthy subjects
with persistent depressive disorder

VANCOUVER, BC, Jan. 4, 2022 /CNW/ – Filament Health Corp. (OTCQB: FLHLF) (NEO: FH) (FSE: 7QS) (“Filament” or the “Company”), a clinical-stage natural psychedelic drug development company, today announced that Health Canada has approved a phase 2 clinical trial which will use the Company’s standardized natural psilocybin drug candidate PEX010 (1 milligram). The trial, studying the safety and efficacy of low doses of psilocybin in healthy subjects with persistent depressive disorder, will be led by Rotem Petranker, Director of the Canadian Centre for Psychedelic Science, and Dr. Norman Farb at the University of Toronto. The trial has received philanthropic funding from the Nikean Foundation.

www.filament.health (CNW Group/Filament Health Corp.)

“We are pleased to support this landmark Canadian trial through the donation of our standardized natural psilocybin,” said Filament Chief Executive Officer, Benjamin Lightburn. “Our team’s involvement in facilitating this trial is an important contribution to the spirit of psychedelic research. We have greatly enjoyed working with Rotem and his team, and look forward to continuing to closely collaborate on this trial. We are excited to learn about new applications for our drug candidates and to gather additional safety data.”

The placebo-controlled phase 2 trial is expected to begin dosing in the first quarter of 2022, and has been designed to include 100 healthy subjects experiencing symptoms of persistent depressive disorder.  The trial will examine the effects of Filament’s botanical drug candidate PEX010 (1 milligram), a newly-developed microdose formulation based on PEX010 (25 milligrams), which previously received approval from the FDA to enter into a phase 1 clinical trial at the University of California San Francisco.

“The Filament Health team has been instrumental in getting this trial up and running,” said Rotem Petranker, Director of the Canadian Centre for Psychedelic Science and the study’s Principal Investigator. “I am excited to work with Filament, whose commitment to professionalism and Open Science has been unwavering. Filament’s product allows us to closely approximate the conditions under which people microdose in the real world, and I expect the results from this study to be very informative.”

ABOUT FILAMENT HEALTH (OTCQB:FLHLF) (NEO:FH) (FSE:7QS)
Filament Health is a clinical-stage natural psychedelic drug development company. We believe that safe, standardized, naturally-derived psychedelic medicines can improve the lives of many, and our mission is to see them in the hands of everyone who needs them as soon as possible. Filament’s platform of proprietary intellectual property enables the discovery, development, and delivery of natural psychedelic medicines for clinical development. We are paving the way with the first-ever natural psychedelic drug candidates.

Learn more at www.filament.health and on Twitter, Instagram and LinkedIn.

FORWARD LOOKING INFORMATION
Certain statements and information contained herein may constitute “forward-looking statements” and “forward-looking information,” respectively, under Canadian securities legislation. Generally, forward-looking information can be identified by the use of forward-looking terminology such as, “expect”, “anticipate”, “continue”, “estimate”, “may”, “will”, “should”, “believe”, “intends”, “forecast”, “plans”, “guidance” and similar expressions are intended to identify forward-looking statements or information. Forward-looking statements herein include, but are not limited to, statements regarding the design and timing of the clinical trial. The forward-looking statements are not historical facts, but reflect the current expectations of management of Filament regarding future results or events and are based on information currently available to them. Certain material factors and assumptions were applied in providing these forward-looking statements. Forward-looking statements regarding the Company are based on the Company’s estimates and are subject to known and unknown risks, uncertainties and other factors that may cause the actual results, levels of activity, performance or achievements of Filament to be materially different from those expressed or implied by such forward-looking statements or forward-looking information, including results of the clinical trial. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking statements and forward-looking information. Filament will not update any forward-looking statements or forward-looking information that are incorporated by reference herein, except as required by applicable securities laws.

SOURCE Filament Health Corp.

This article was published by CFN Enterprises Inc. (OTCQB: CNFN), owner and operator of CFN Media, the industry’s leading agency and digital financial media network dedicated to the burgeoning CBD and legal cannabis industries. Call +1 (833) 420-CNFN for more information.

About Ryan Allway

Mr. Allway has over a decade of experience in the financial markets as both a private investor and financial journalist. He has been actively involved in the cannabis industry since its inception, covering public and private companies.


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Canntab Receives Medical Sales Licence from Health Canada https://mjshareholders.com/canntab-receives-medical-sales-licence-from-health-canada/ Thu, 11 Nov 2021 23:33:14 +0000 https://www.cannabisfn.com/?p=2935889

Ryan Allway

November 11th, 2021


TORONTONov. 11, 2021 /CNW/ – Canntab Therapeutics Limited (CSE: PILL.CN) (OTCQB: CTABF) (FRA: TBF1.F) (the “Company” or “Canntab”), the leading innovator in cannabinoid and terpene blends in hard pill form for therapeutic applications, is pleased to announce that it has received its medical sales license from Health Canada for its Markham, Ontario facility, enabling the sale of all products directly to medical consumers.

Canntab Therapeutics Limited (CNW Group/Canntab Therapeutics Limited)
Canntab Therapeutics Limited (CNW Group/Canntab Therapeutics Limited)

The amendment marks the final regulatory step required to launch the company’s direct to consumer website, allowing patients across Canada to order online the unique patented exact dosage hard tablets and caplets of THC and CBD in various strengths. Exact dosing is a key element in the Canntab offering in addressing the needs of the medical community.

Larry Latowsky, Canntab’s CEO, stated, “The sales amendment is the most significant milestone to date for our company, and provides Canntab with the legal ability to aggressively move forward with our business plan and full commercialization of our brand and products.” Mr. Latowsky added that, “Our web site (www.canntab.ca) and e-commerce focus will be the primary vehicle in generating sustained and growing revenue. We have been hard at work in soliciting and preparing our many affiliate partners in anticipation of this day for the past many months and look forward to providing essential medical product to their significant groups of customers. Affiliates across Canada like pharmacy groups, health and wellness practitioners, sleep and pain clinics and other medical professionals will now be able to recommend or prescribe our product and be fully compensated.”

Mr. Latowsky further added that, “Over the next several weeks, we expect to announce many partnerships that will extend to a large percentage of the Canadian population to provide specific programs from opiate alternative solutions to general health and wellness programs, as well as the Ontario Cannabis Store and other provincial authorities. A lot of hard work went into achieving this significant milestone and being approved as the first Canadian hard pill THC and CBD medical provider speaks to the dedication of our team and to the patience of our investors as we now move forward to create value for all stakeholders providing solutions for patients across the country.”

Options Granted

Canntab has granted, in accordance with the Company’s stock option plan, an aggregate of 120,000 options to purchase common shares of the Company to two (2) consultants of the Company. Each consultant received 60,000 options. Each option is exercisable at a price of $0.80 per share for a period of two years, expiring November 9, 2023.

OCS Order Schedule

The Company’s initial order to the Ontario Cannabis Stores (“OCS”) scheduled for November, has been rescheduled for January with additional product scheduled for March.

About Canntab Therapeutics

Canntab Therapeutics is a Canadian biopharmaceutical company focused on the manufacturing and distribution of a suite of hard pill cannabinoid formulations in multiple doses and timed-release combinations. Long referred to as Cannabis 3.0 by the Company, Canntab’s proprietary hard pill cannabinoid formulations provide doctors, patients and consumers with medical grade solutions which incorporate all the features one would expect from any prescription or over the counter medication sold in pharmacies around the world. These will include the following formulations: once a day and extended release, both providing an accurate dose and improved shelf stability.

Canntab holds a Cannabis Standard Processing & Sales for Medical Purposes License, a Cannabis Research License, and an Industrial Hemp License from Health Canada.

Canntab trades on the Canadian Securities Exchange under the symbol PILL, on the OTCQB under the symbol CTABF, and on the Frankfurt Stock Exchange under the symbol TBF1.

Forward Looking Statements

This news release contains “forward-looking statements” within the meaning of applicable securities laws. All statements contained herein that are not clearly historical in nature may constitute forward-looking statements.

Generally, such forward-looking information or forward-looking statements can be identified by the use of forward-looking terminology such as “plans”, “expects” or “does not expect”, “is expected”, “budget”, “scheduled”, “estimates”, “forecasts”, “intends”, “anticipates” or “does not anticipate”, or “believes”, or variations of such words and phrases or may contain statements that certain actions, events or results “may”, “could”, “would”, “might” or “will be taken”, “will continue”, “will occur” or “will be achieved”. The forward-looking information and forward- looking statements contained herein include, but are not limited to, statements regarding: the ability of the Company to launch its direct to consumer website; the Company’s ability to generate sustained and growing revenue; the recommendation of the Company’s products by healthcare professionals; the announcement of partnerships; the ability of those partnerships to give the Company access to a large percentage of the Canadian population; the ability of the Company to complete the initial order with the OCS; and the ability of the Company’s products to carry out the enumerated functions.

Forward-looking information in this news release are based on certain assumptions and expected future events, namely: the Company’s ability to continue as a going concern; the continued commercial viability and growth in popularity of the Company’s products; continued approval of the Company’s activities by the relevant governmental and/or regulatory authorities; and the continued growth of the Company.

These statements involve known and unknown risks, uncertainties and other factors, which may cause actual results, performance or achievements to differ materially from those expressed or implied by such statements, including but not limited to: the potential inability of the Company to continue as a going concern; the risks associated with the cannabis and pharmaceutical industries in general; increased competition in the cannabis and pharmaceutical markets; the potential future unviability of the Company’s products; risks associated with potential governmental and/or regulatory action with respect to the cannabis products; risks associated with a potential collapse in the value of cannabis products; risks associated with the Company’s ability to continue generating a profit; the inability of the Company to launch its direct to consumer website; the Company’s ability to generate sustained and growing revenue; risks that the Company’s products will not be adopted and/or recommended by healthcare professionals; the inability of the Company to execute partnerships; the inability of the Company to access to a large percentage of the Canadian population through the execution of partnerships; the inability of the Company to complete the initial order with the OCS; and risks that the Company’s products may not carry out the enumerated functions.

Readers are cautioned that the foregoing list is not exhaustive. Readers are further cautioned not to place undue reliance on forward-looking statements, as there can be no assurance that the plans, intentions or expectations upon which they are placed will occur. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated.

Forward-looking statements contained in this news release are expressly qualified by this cautionary statement and reflect the Company’s expectations as of the date hereof and are subject to change thereafter. The Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, estimates or opinions, future events or results or otherwise or to explain any material difference between subsequent actual events and such forward-looking information, except as required by applicable law.

This article was published by CFN Enterprises Inc. (OTCQB: CNFN), owner and operator of CFN Media, the industry’s leading agency and digital financial media network dedicated to the burgeoning CBD and legal cannabis industries. Call +1 (833) 420-CNFN for more information.

About Ryan Allway

Mr. Allway has over a decade of experience in the financial markets as both a private investor and financial journalist. He has been actively involved in the cannabis industry since its inception, covering public and private companies.


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