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Depression free for 1 year

Psychedelic therapy for depression still effective one year later

Johns Hopkins researchers followed up with patients one year after receiving psilocybin therapy. They found that 75% of patients sustained significant reductions in depression scores and 58% no longer qualified for a diagnosis. 

However, about a third of patients also used traditional antidepressants and 42% received additional psychotherapy at some point during the year.

So although psilocybin therapy can have rapid results, multiple treatment options can help sustain the benefits.

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Shroom use →  less crime

Psilocybin use associated with lowered odds of having been arrested, study finds

People who use shrooms are less likely to commit crimes, according to new research.

An analysis of The National Survey on Drug Use and Health found that psilocybin use is linked to significantly reduced odds of arrest for:

  • Larceny
  • Burglary & robbery
  • Simple assault & battery
  • Serious violence
  • DUI
  • And other miscellaneous crimes

LSD appeared to have no impact on crime rates 🤔

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Is microdosing a placebo? 💊

Nova Mentis Study Confirms Oral Microdose Psilocybin Treatment of Autism

This week, Nova Mentis (NOVA) announced that rats with cognitive impairments showed improvements in memory when given a microdose of psilocybin every other day for just two weeks.

However, a new University of Chicago study found no effect on mood or task performance after giving healthy volunteer 4 LSD microdoses 3-4 days apart in a placebo-controlled study.

Could it be that a more frequent dose is needed to see benefits? Or is psilocybin faster acting than LSD? Or maybe microdosing is a placebo after all.

Stay tuned as we follow along with the latest research. 

Novamentis
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Unanimous win for Hawaii

Hawaii Senators Approve Psilocybin Task Force Bill In Committee, With Decriminalization Measures Still Pending

Hawaii senators unanimously passed a bill to create a psilocybin research task force and develop a long-term strategy to make treatments accessible and affordable.

The state also has a bill to decriminalize psilocybin and establish psilocybin treatment centers, which remains active but has yet to be scheduled for committee hearings.

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Core One Labs Completes Strategic Acquisition of Awakened Biosciences and its Game-Changing Provisional Patents

Core One Labs Completes Strategic Acquisition of Awakened Biosciences and its Game-Changing Provisional Patents

Vancouver, British Columbia, Canada – February 11, 2022 – Core One Labs Inc. (CSE: COOL), (OTC: CLABF), (Frankfurt: LD6, WKN: A3CSSU) (the “Company” or “Core One”), a life sciences biotechnology company focused on research, development, and production of API grade psychedelic compounds, as well as the advancement of psychedelic assisted treatments for various mental health and neurological disorders, is pleased to announce that it has completed the acquisition (the “Transaction”) of all of the outstanding share capital of Awakened Biosciences Inc. (“Awakened”).

Awakened is a psychedelics research and technology company that has successfully developed novel technologies for the production of synthetic psilocybin, the synthetic production of psilocybin and psilocin analogues, and for the manufacturing of various no-psychoactive psilocybin-based prodrugs.  All of Awakened’s production methods have the potential to produce resultant compounds at scale, and at significantly reduced costs when compared to other production methods of the same name.

Awakened’s novel production methods have resulted in the filing of three (3) provisional patents applications with the United States Patent and Trademark Office (USPTO) for protection of these proprietary technologies.

The Transaction presents many significant and immediate benefits to the Company, including expanding the Company’s portfolio of subsidiaries specializing in the research and development of psychedelic compounds, as well as an expansion in the spectrum of methods Core One’s scientists can employ in producing psychedelic-based formulations.

Successful employment of Awakened’s patent-pending production technologies could also result in revenue generation for the Company, as some of the patent-pending methods, and resultant analogues produced, could be sold, and shipped without Controlled Drug and Substances Act (CDSA) restrictions.

The Transaction also increases the Company’s catalogue of psychedelic compounds available for clinical and medicinal research, including an array of prodrugs that would be produced from the new technologies.

Normally designed to improve bioavailability, a prodrug is described as a medication or a compound that is metabolized into a pharmacologically active drug after administration. For psychedelic compounds, prodrugs would contain the same medicinal benefits associated with psychedelics while eliminating the hallucinogenic effects.

Awakened is led by Dr. Tony Durst, an Emeritus Professor at the University of Ottawa, and renowned specialist in medicinal and natural product chemistry. Dr. Durst is a co-inventor of 14 patents applications, 14 awarded.  He is a founder of Souroubea Botanicals Inc., and a 2013 Queen Elizabeth 60th Silver Jubilee medal recipient.

The addition of Dr. Durst, along with his established relationship with the University of Ottawa, further compliments Core One’s strong scientific team led by Dr. Robert Hancock, CEO of the Company’s subsidiary Vocan Biotechnology, and establishes a relationship with another one of Canada’s leading scientific research universities, as the Company continues to build an impressive roster of leading scientific researchers.

“This acquisition is yet another illustration of Core One’s commitment to become a leading biotechnology and life sciences enterprise in the psychedelic sector. With the addition of Awakened to the Core One family, the Company has increased expansion opportunities, furthered its psychedelic products portfolio, and secured potential for immediate revenue generation. All of these factors lead toward greater market share for the Company, and to increased shareholder value,” stated Joel Shacker, Core One CEO.

Transaction Details

The Transaction was completed pursuant to a share purchase agreement among the Company, Awakened and the shareholders of Awakened (the “Definitive Agreement”) dated effective February 9, 2022.  Pursuant to the Definitive Agreement, and in consideration for the acquisition of Awakened, the Company has issued 7,030,000 common shares and 1,458,200 share purchase warrants entitling the holders to acquire an equivalent number of common shares of the Company at a price of $1.15 per share until February 4, 2024.

The Company is at arms-length from Awakened and its shareholders.  The Transaction neither constitutes a fundamental change nor a change of business for the Company, nor has it resulted in a change of control of the Company within the meaning applicable securities laws and the policies of the Canadian Securities Exchange.  In connection with completion of the Transaction, the Company has issued 140,600 common shares to certain third-parties who provided administrative services necessary to complete the Transaction.

About Core One Labs Inc.

Core One is a biotechnology research and technology life sciences enterprise focused on bringing psychedelic medicines to market through novel delivery systems and psychedelic assisted psychotherapy. Core One has developed a patent pending thin film oral strip (the “technology”) which dissolves instantly when placed in the mouth and delivers organic molecules in precise quantities to the bloodstream, maintaining excellent bioavailability. The Company intends to further develop and apply the technology to psychedelic compounds, such as psilocybin. Core One also holds an interest in medical clinics which maintain a combined database of over 275,000 patients. Through these clinics, the integration of its intellectual property, R&D related to psychedelic treatments and novel drug therapies, the Company intends to obtain regulatory research approval for the advancement of psychedelic-derived treatments for mental health disorders.

Core One Labs Inc.

Joel Shacker

Chief Executive Officer

FOR MORE INFORMATION, PLEASE CONTACT:

info@core1labs.com

1-866-347-5058

Cautionary Disclaimer Statement:

The Canadian Securities Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of the content of this news release.

Information set forth in this news release contains forward-looking statements that are based on assumptions as of the date of this news release. These statements reflect management’s current estimates, beliefs, intentions, and expectations. They are not guarantees of future performance. The Company cautions that all forward-looking statements are inherently uncertain, and that actual performance may be affected by a number of material factors, many of which are beyond the Company’s control. Such factors include, among other things: risks and uncertainties relating to the Company’s limited operating history and the need to comply with strict regulatory regulations.  Accordingly, actual and future events, conditions and results may differ materially from the estimates, beliefs, intentions and expectations expressed or implied in the forward-looking information. Except as required under applicable securities legislation, the Company undertakes no obligation to publicly update or revise forward-looking information.

In addition, psilocybin is currently a Schedule III drug under the Controlled Drugs and Substances Act (Canada) and it is a criminal offence to possess substances under the Controlled Drugs and Substances Act (Canada) without a prescription or authorization. Health Canada has not approved psilocybin as a drug for any indication. Core One does not have any direct or indirect involvement with illegal selling, production, or distribution of psychedelic substances in jurisdictions in which it operates. While Core One believes psychedelic substances can be used to treat certain medical conditions, it does not advocate for the legalization of psychedelics substances for recreational use. Core One does not deal with psychedelic substances, except within laboratory and clinical trial settings conducted within approved regulatory frameworks.

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Core One Labs’ Successful Patent Application Filing for Protection of its Biosynthetic Production System for Psilocybin Marks a Significant Milestone for the Progression of Psychedelic Health Care

Core One Labs’ Successful Patent Application Filing for Protection of its Biosynthetic Production System for Psilocybin Marks a Significant Milestone for the Progression of Psychedelic Health Care

Vancouver, British Columbia, Canada – February 9, 2022 – Core One Labs Inc. (CSE: COOL), (OTC: CLABF), (Frankfurt: LD6, WKN: A3CSSU) (the “Company” or “Core One”) is pleased to announce that following its milestone announcement that its wholly-owned subsidiary, Vocan Biotechnologies Inc. (Vocan), has successfully engineered a novel recombinant production system for biologically synthesized (biosynthesized) psilocybin, and has filed for patent protection of its groundbreaking intellectual property (see Core One’s press release dated January 21, 2022), its team of scientist continue to make progress and are in the process of optimizing at scale production capacity.

Scaled up production of the Company’s groundbreaking biosynthetic psilocybin, and an approval of the Company’s patent application will further Core One and Vocan’s journey to becoming a significant player in the provision of cost effective psilocybin and has the potential to significantly change the face of psychedelic-based mental health care and patient access to alternative treatments around the globe.

Psilocybin is a psychedelic compound that is showing enormous promise in treating addiction and many mental health disorders; and the success of this game-changing patent propels Core One to the forefront of the rapidly expanding psychedelics industry, eliminating barriers for psychedelic treatments and research such as exorbitant costs and lack of availability and supply.

Currently, most companies use chemically synthesized psilocybin as the only available cGMP compliant product that is available in large volumes. The chemical process carries significant costs and is less efficient when compared to a biologically derived psilocybin.

Under the leadership of Dr. Jan Burian, Vocan’s Chief Scientist, and Dr. Robert EW Hancock, Vocan’s CEO, the team’s ground-breaking psilocybin production method utilizes the well-established industrial process of fermentation and therefore can be scaled up while consistently producing a high-quality cGMP product. The process turns bacteria into a biological factory to produce synthesized psilocybin, cutting cost and time immensely.

With Vocan’s optimized recombinant production system, the subsidiary successfully tested its proof-of-concept for the manufacturing of biosynthetic psilocybin suitable for use in future scale-up and is awaiting patent approval. The application includes claims that Vocan’s technology will enable the production of cGMP API grade psilocybin, which can be used by pharmaceutical companies, API manufacturers and organizations conducting clinical trials and, where permitted by law, consumers, and patients. Vocan’s crucial breakthrough anticipates a rippling effect that could rearrange the industry’s landscape hereafter.

“This breakthrough in psilocybin production, can shift the entire industry. By making psychedelic treatments cost effective, this could make treatment more widely available to patients globally. Additionally, our patent on this process, gives us first mover advantage in this significant and emerging space,” Stated Joel Shacker CEO of the Company.

About Core One Labs Inc.

Core One is a biotechnology research and technology life sciences enterprise focused on bringing psychedelic medicines to market through novel delivery systems and psychedelic assisted psychotherapy. Core One has developed a patent pending thin film oral strip (the “technology”) which dissolves instantly when placed in the mouth and delivers organic molecules in precise quantities to the bloodstream, maintaining excellent bioavailability. The Company intends to further develop and apply the technology to psychedelic compounds, such as psilocybin. Core One also holds an interest in medical clinics which maintain a combined database of over 275,000 patients. Through these clinics, the integration of its intellectual property, R&D related to psychedelic treatments and novel drug therapies, the Company intends to obtain regulatory research approval for the advancement of psychedelic-derived treatments for mental health disorders.

Core One Labs Inc.

Joel Shacker

Chief Executive Officer

FOR MORE INFORMATION, PLEASE CONTACT:

info@core1labs.com

1-866-347-5058

Cautionary Disclaimer Statement:

The Canadian Securities Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of the content of this news release.

Information set forth in this news release contains forward-looking statements that are based on assumptions as of the date of this news release. These statements reflect management’s current estimates, beliefs, intentions, and expectations. They are not guarantees of future performance. The Company cautions that all forward-looking statements are inherently uncertain, and that actual performance may be affected by a number of material factors, many of which are beyond the Company’s control. Such factors include, among other things: risks and uncertainties relating to the Company’s limited operating history and the need to comply with strict regulatory regulations.  Accordingly, actual and future events, conditions and results may differ materially from the estimates, beliefs, intentions and expectations expressed or implied in the forward-looking information. Except as required under applicable securities legislation, the Company undertakes no obligation to publicly update or revise forward-looking information.

In addition, psilocybin is currently a Schedule III drug under the Controlled Drugs and Substances Act (Canada) and it is a criminal offence to possess substances under the Controlled Drugs and Substances Act (Canada) without a prescription or authorization. Health Canada has not approved psilocybin as a drug for any indication. Core One does not have any direct or indirect involvement with illegal selling, production, or distribution of psychedelic substances in jurisdictions in which it operates. While Core One believes psychedelic substances can be used to treat certain medical conditions, it does not advocate for the legalization of psychedelics substances for recreational use. Core One does not deal with psychedelic substances, except within laboratory and clinical trial settings conducted within approved regulatory frameworks.

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Psilocybin therapy bill rejected in Maine, sponsor confident it will pass in the future

Lawmakers say no to bill legalizing psilocybin-assisted therapy in Maine

Maine lawmakers rejected a bill that would legalize medical use of psilocybin after an 8-3 vote. The bill’s sponsor says she’s not surprised, however “society is changing, and the science is moving quickly, so it’s a matter of when, and not if, legislation like this passes in the future.”

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Mydecine’s Exclusive Dealer Identified as Licensed Psilocybin and MDMA Supplier in Canada

Mydecine’s Exclusive Dealer Identified as Licensed Psilocybin and MDMA Supplier in Canada

Mydecine now able to supply cGMP products to healthcare providers for patients with serious and life-threatening conditions through the Special Access Program

VANCOUVER, British Columbia, Feb. 08, 2022 (GLOBE NEWSWIRE) — Mydecine Innovations Group Inc. (NEO: MYCO) (OTC: MYCOF) (FSE: 0NFA) (“Mydecine” or the “Company”), a biotechnology company aiming to transform the treatment of mental health and addiction disorders, today announced that Health Canada has included the dealer’s license Mydecine operates under as a supplier for the Special Access Program, which allows healthcare providers to request specific drugs for approved patients who have not responded to other available treatment options.

The licensed dealer facility, available to Mydecine through its exclusive agreement with Applied Pharmaceutical Innovation (API), contains a unique research and development infrastructure as well as a manufacturing facility in Edmonton, Canada. With the license, Mydecine is able to provide psilocybin and MDMA  that meet Current Good Manufacturing Practices (cGMP) through Health Canada’s Special Access Program (SAP). This program allows practitioners to request psilocybin and MDMA for a patient with a serious or life-threatening condition where conventional treatments have failed, are unsuitable, or are generally not available in Canada.

“While we will continue to advance the research of psychedelic-assisted psychotherapy through our clinical trials and drug development process, we understand there are patients in need of treatments today. Through our dealer’s license, we can offer psilocybin and MDMA to practitioners and clinics in Canada who want to offer these treatment options for patients in need,” said Mydecine Chief Medical Officer Dr. Rakesh Jetly.

Following the addition of psilocybin and MDMA to Health Canada’s SAP in January, Mydecine launched its Special Access Support and Supply Program for physicians, clinics and hospitals throughout Canada, providing access to cGMP products, protocol training, therapy manuals, and technology to ensure safe and effective therapy outcomes for patients.

Sign-up for Mydecine’s newsletter by scrolling to the bottom of this page.

About Mydecine Innovations Group

Mydecine Innovations Group™ (NEO:MYCO) (OTC:MYCOF) (FSE:0NFA) is a biotechnology company developing innovative first- and-second-generation novel therapeutics for the treatment of mental health and addiction using world-class technology and drug development infrastructure. Mydecine was founded in 2020 to address a significant unmet need and lack of innovation in the mental health and therapeutic treatment environments. Our global team is dedicated to efficiently developing new therapeutics to treat PTSD, depression, anxiety, addiction and other mental health disorders. The Mydecine business model combines clinical trials and data outcome, technology, and scientific and regulatory expertise with a focus on psychedelic therapy, as well as other novel, non-psychedelic molecules with therapeutic potential. By collaborating with some of the world’s foremost authorities, Mydecine aims to responsibly fast-track the development of new medicines to provide patients suffering from mental health disorders with safe and more effective treatment options. Mydecine Innovations Group is headquartered in Denver, Colorado, USA, with international offices in Leiden, Netherlands.

Learn more at: https://www.mydecine.com and follow us on Twitter, LinkedIn, and Instagram.

For more information, please contact:
Media Contact
Morgan Kervitsky, Director of Marketing
pr@mydecineinc.com

Investor Relations
Morgan Kervitsky, Director of Marketing
contact@mydecineinc.com

On behalf of the Board of Directors:
Joshua Bartch, Chief Executive Officer
contact@mydecineinc.com

For further information about Mydecine Innovations Group, Inc., please visit the Company’s profile on SEDAR at www.sedar.com or visit the Company’s website at www.mydecine.com.

This news release contains forward-looking information within the meaning of Canadian securities laws regarding the Company and its business, which relate to future events or future performance and reflect management’s current expectations and assumptions. Often but not always, forward-looking information can be identified by the use of words such as “expect”, “intends”, “anticipated”, “believes” or variations (including negative variations) of such words and phrases, or state that certain actions, events or results “may”, “could”, “would” or “will” be taken, occur or be achieved. Such forward-looking statements reflect management’s current beliefs and are based on assumptions made by and information currently available to the Company. Readers are cautioned that these forward-looking statements are neither promises nor guarantees, and are subject to risks and uncertainties that may cause future results to differ materially from those expected including, without limitation, risks regarding the COVID-19 pandemic, the availability and continuity of financing, the ability of the Company to adequately protect and enforce its intellectual property, the Company’s ability to bring its products to commercial production, continued growth of the global adaptive pathway medicine, natural health products and digital health industries, and the risks presented by the highly regulated and competitive market concerning the development, production, sale and use of the Company’s products. Although the Company has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking information, there may be other factors that cause results not to be as anticipated, estimated or intended. There can be no assurance that such information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such information. These forward-looking statements are made as of the date hereof and the Company does not assume any obligation to update or revise them to reflect new events or circumstances save as required under applicable securities legislation.

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Source: Mydecine Innovations Group Inc.

Released February 8, 2022

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Optimi Health Dealer’s License Granted by Health Canada

Optimi Health Dealer’s License Granted by Health Canada

Optimi Health (OPTI) received a Dealer’s License from Health Canada and announced that it will begin cultivating, extracting, and processing “the highest-grade all-natural psilocybin in North America” at its facility in Princeton, British Columbia. The facility can secure up to 1,250kg of psilocybin, a value of roughly $53MM CDN.

OptimiTM

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Psyence Awarded ISO Certification through the British Standards Institute for its Natural Psilocybin Production Facility

Psyence Awarded ISO Certification through the British Standards Institute for its Natural Psilocybin Production Facility

TORONTO, 7 February, 2022 – Psyence Group Inc. (CSE: PSYG | OTCQB: PSYGF) (“Psyence” or the “Company”), a life science biotechnology company pioneering the use of natural psychedelics in mental health and well-being, is pleased to announce that its ISO22000 graded Psilocybin production facility has officially received International Organization for Standardization (ISO) 22000:2018 certification, awarded through the British Standards Institute (BSI). ISO 22000 is a globally accepted international standard that specifies the requirements for food safety management systems.

Psyence’s facility, which is federally licensed to cultivate and export psilocybin mushrooms for the legal medical and research markets, is based in Southern Africa and has been operational since January 2021. The facility was designed and constructed to ISO 14644-1 cleanroom specifications and engineering design principles. This design allows various parts of the process to comply with the Good Manufacturing Practice (GMP) Standards required for product safety and quality in order to meet the certification needs of the BSI. The facility is equipped with validated and calibrated specialised equipment to ensure optimum growing conditions and efficient harvesting and packaging. With this certification, Psyence is one step closer to producing pharmaceutical grade product for human clinical trials, including Psyence’s clinical trial in the field of palliative care and clinical trials run by research organisations.

Tony Budden, Psyence Chief Strategy Officer, and Head of Psyence Production, says that the awarding of BSI certification is an important milestone for Psyence.

“As a science-led company we are committed to producing high quality, natural psilocybin. ISO22000: 2018 certification gives our drug development partners and, ultimately, consumers, assurance that our production processes meet globally recognized standards. With this certification awarded by the BSI we are reassured that our equipment and processes are performing to the high standards required by the BSI, that our staff are skilled and experienced, and that our standard operating procedures are efficient and validated.”

“Psyence used the ISO 22000:2018 Quality Management system as the base for its BSI certification. Set by the ISO, ISO 22000:2018 creates a single product safety standard that harmonizes the various national standards into one set of requirements that are globally accredited,” says Yasin Khan, Psyence Quality Assurance Manager.

“As part of the ISO 22000 process we had to conclude three successful and approved validation batches, all of which had to be audited. This is to ensure a consistent end product in terms of safety and quality. The audits were concluded in December 2021 enabling Psyence to achieve ISO 22000:2018 certification through the BSI,” explains Khan.

ABOUT PSYENCE GROUP: www.psyence.com

Psyence is a life science biotechnology company listed on the Canadian Securities Exchange and (CSE: PSYG) and quoted on the OTCQB (OTCQB: PSYGF), with a focus on natural psychedelics. Psyence works with natural psilocybin products for the healing of psychological trauma and its mental health consequences in the context of palliative care.

Our name “Psyence” combines the words psychedelic and science to affirm our commitment to producing psychedelic medicines developed through evidence-based research.

Informed by nature and guided by science, we built and operate one of the world’s first federally licensed commercial psilocybin mushroom cultivation and production facilities in Lesotho, Southern Africa. Our team brings international experience in both business and science and includes experts in mycology, neurology, palliative care, and drug development.  We work to develop advanced natural psilocybin products for clinical research and development.

Our key divisions, Psyence Production, Psyence Therapeutics, and Psyence Function, anchor an international collaboration, with operations in Canada, the United Kingdom, Jamaica, South Africa and Lesotho, and a presence in the United States and Australia.

Contact Information:

Katherine Murphy, Investor Relations

Email: ir@psyence.com

Media Inquiries: media@psyence.com

General Information: info@psyence.com

FORWARD LOOKING STATEMENTS:

Certain statements in this news release related to Psyence Group Inc and its subsidiaries (collectively the “Company“) are forward-looking statements and are prospective in nature. Forward-looking statements are not based on historical facts, but rather on current expectations and projections about future events and are therefore subject to risks and uncertainties which could cause actual results to differ materially from the future results expressed or implied by the forward-looking statements. These statements generally can be identified by the use of forward-looking words such as “may”, “should”, “could”, “intend”, “estimate”, “plan”, “anticipate”, “expect”, “believe” or “continue”, or the negative thereof or similar variations. Forward-looking statements in this news release include statements regarding future product development and the successful commencement of clinical trials, both of which remain subject to regulatory approvals and registration. These forward-looking statements are based on a number of assumptions, including the assumptions that the Company’s applications for human clinical trials will be successful and that its product will be suitable for use in human clinical trials. 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. These risks and uncertainties include demand for the Company’s securities being less than anticipated, fluctuations in the price the Company’s common shares, and the Company not raising the amount expected, or any funds at all. Actual results and future events could differ materially from those anticipated in such information. 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.

The Company makes no medical, treatment or health benefit claims about the Company’s proposed products. The U.S. Food and Drug Administration, Health Canada or other similar regulatory authorities have not evaluated claims regarding psilocybin, psilocybin analogues, or other psychedelic compounds or nutraceutical products. The efficacy of such products has not been confirmed by approved research. There is no assurance that the use of psilocybin, psilocybin analogues, or other psychedelic compounds or nutraceuticals can diagnose, treat, cure or prevent any disease or condition. Vigorous scientific research and clinical trials are needed. The Company has not conducted clinical trials for the use of its proposed products. Any references to quality, consistency, efficacy, and safety of potential products do not imply that the Company verified such in clinical trials or that the Company will complete such trials. If the Company cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on the Company’s performance and operations.