DOCSLIB.ORG

(Formerly Known As Hinterland Metals Inc.) LISTING STATEMENT FORM

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text

Load more

NOVAMIND INC. (formerly known as Hinterland Metals Inc.) LISTING STATEMENT FORM 2A December 30, 2020 TABLE OF CONTENTS Page No. 1. GLOSSARY OF TERMS ............................................................................................................. 3 2. CORPORATE STRUCTURE ................................................................................................... 10 3. GENERAL DEVELOPMENT OF THE BUSINESS .............................................................. 11 4. NARRATIVE DESCRIPTION OF THE BUSINESS ............................................................. 17 5. SELECTED CONSOLIDATED FINANCIAL INFORMATION .......................................... 37 6. MANAGEMENT’S DISCUSSION AND ANALYSIS ............................................................. 39 7. MARKET FOR SECURITIES .................................................................................................. 39 8. CONSOLIDATED CAPITALIZATION .................................................................................. 39 9. OPTIONS TO PURCHASE SECURITIES .............................................................................. 40 10. DESCRIPTION OF THE SECURITIES .................................................................................. 41 11. ESCROWED SECURITIES ...................................................................................................... 46 12. PRINCIPAL SHAREHOLDERS .............................................................................................. 47 13. DIRECTORS AND OFFICERS ................................................................................................ 48 14. CAPITALIZATION ................................................................................................................... 56 15. EXECUTIVE COMPENSATION ............................................................................................. 59 16. INDEBTEDNESS OF DIRECTORS AND EXECUTIVE OFFICERS ................................. 62 17. RISK FACTORS ......................................................................................................................... 62 18. PROMOTERS ............................................................................................................................. 71 19. LEGAL PROCEEDINGS .......................................................................................................... 71 20. INTEREST OF MANAGEMENT AND OTHERS IN MATERIAL TRANSACTIONS ....................................................................................................................... 71 21. AUDITORS, TRANSFER AGENTS AND REGISTRARS .................................................... 71 22. MATERIAL CONTRACTS ...................................................................................................... 72 23. INTEREST OF EXPERTS ........................................................................................................ 72 24. OTHER MATERIAL FACTS ................................................................................................... 72 25. FINANCIAL STATEMENTS .................................................................................................... 73 SCHEDULE “A” - PRO FORMA FINANCIAL STATEMENTS SCHEDULE “B” - HINTERLAND FINANCIAL STATEMENTS SCHEDULE “C” - NOVAMIND FINANCIAL STATEMENTS SCHEDULE “D” - HINTERLAND MD&A SCHEDULE “E” - NOVAMIND MD&A SCHEDULE “F” - CEDAR PSYCHIATRY AND CCR FINANCIAL STATEMENTS SCHEDULE “G” - CEDAR PSYCHIATRY AND CCR MD&A Cautionary Note Regarding Forward-Looking Statements This Listing Statement contains forward-looking information (collectively, “forward-looking information”), which includes disclosure regarding possible events, conditions or financial performance that is based on assumptions about future economic conditions and courses of action. Often, but not always, forward-looking information can be identified by the use of words such as “plans”, “expects” or “does not expect”, “is expected”, “estimates”, “intends”, “anticipates”, “projects”, “budgets”, “forecasts” or “does not anticipate”, or “believes”, or variations of such words and phrases, or statements that certain actions, events or results “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved. Examples of such forward-looking information in this Listing Statement includes disclosure relating to the following: the Corporation’s business and operations; the Corporation’s anticipated revenues and cash flows from operations and consequent funding requirements; the funds available to the Corporation and the principal purposes of those funds; the Corporation’s business objectives and discussion of trends affecting the business of the Corporation; and the Corporation’s anticipated operating expenses. Actual results and developments are likely to differ, and may differ materially, from those expressed or implied by the forward-looking information contained in this Listing Statement. The forward-looking information in this Listing Statement is based on a number of assumptions that may prove to be incorrect, including, but not limited to the following: general economic conditions; the ability of the Corporation to accurately assess and anticipate trends in its industry; the ability of the Corporation to realize its business objectives and manage its cash flow; the Corporation’s ability to maintain a competitive position; the ability of the Corporation to obtain any necessary financing; and the ability of the Corporation to maintain current operating expenses. Forward-looking information involves known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Corporation to be materially different from any future results, performance or achievements expressed or implied by the forward-looking information. Some of these risks, include, but are not limited to the following: Revenue is largely reliant on payments received from government and third-party payors; Regulatory Risks; Permits and Licenses; Changes in Laws, Regulations and Guidelines; General Healthcare Regulations; Limited Operating History; Reliance on Physicians and other Healthcare Professionals; Confidentiality of Personal and Health Information; Insurance and Uninsured Risks; Business Exposure to New Clinical Modalities; Dependence on Suppliers and Skilled Labour; Difficulty to Forecast; Management of Growth; Business Development and Expansion Risks; Requirement for Additional Financing; Share Dilution; Liquidity; Litigation; The Effects of Health Epidemics (Including the Global COVID-19 Pandemic); Economic Dependence; Risks Associated with the Regulated Psychedelics Industry; Risks related to the Truffles Industry; Unfavourable Publicity or Consumer Perception Towards Psychedelics; Risks Associated with the Medical Cannabis Market; Entry Bans into the United States; Competition; Market Unpredictability; Fraudulent or Illegal Activity; Reliance on Information Technology Systems and Cyberattacks; Conflicts of Interest; Internal Controls; Supply Risk; Stock Price Volatility; Limited Market for Securities. The factors identified above are not intended to represent a complete list of the factors that could affect the Corporation. Additional risk factors are noted under the heading “Risk Factors”. Should one or more of these risks or uncertainties materialize, or should assumptions underlying the forward-looking information prove incorrect, actual results, performance or achievement may vary materially from those expressed or implied by the forward-looking information contained in this Listing Statement. These risk factors should be carefully considered and readers are cautioned not to place undue reliance on forward-looking information, which speaks only as of the date of this Listing Statement. The Corporation does not undertake any obligation to release publicly any revisions to this forward-looking information to reflect events or circumstances that occur after the date of this Listing Statement or to reflect the occurrence of unanticipated events, except as may be required under applicable securities laws. Market and Industry Data This Listing Statement includes market and industry data that has been obtained from third party sources, including industry publications. The Corporation believes that its industry data is accurate and that its estimates and assumptions are reasonable, but there is no assurance as to the accuracy or completeness of this data. Third-party sources generally state that the information contained therein has been obtained from sources believed to be reliable, but there is no assurance as to the accuracy or completeness of included information. Although the data is believed to be reliable, the Corporation has not independently verified any of the data from third-party sources referred to in this Listing Statement or ascertained the underlying economic assumptions relied upon by such sources. 2 1. GLOSSARY OF TERMS The following is a glossary of certain general terms used in this Listing Statement including the summary hereof. Terms and abbreviations used in the financial statements included in or appended to this Listing Statement are defined separately and the terms and abbreviations defined below are not used therein, except where otherwise indicated. Words importing the singular, where the context requires, include the plural and vice versa and words importing any gender include all genders. “Acquireco” means 2784326 Ontario Inc., which
Recommended publications
  • WO 2017/145013 Al 31 August 2017 (31.08.2017) P O P C T

    WO 2017/145013 Al 31 August 2017 (31.08.2017) P O P C T

    (12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (10) International Publication Number (43) International Publication Date WO 2017/145013 Al 31 August 2017 (31.08.2017) P O P C T (51) International Patent Classification: (81) Designated States (unless otherwise indicated, for every C07D 498/04 (2006.01) A61K 31/5365 (2006.01) kind of national protection available): AE, AG, AL, AM, C07D 519/00 (2006.01) A61P 25/00 (2006.01) AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DJ, DK, DM, (21) Number: International Application DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, PCT/IB20 17/050844 HN, HR, HU, ID, IL, IN, IR, IS, JP, KE, KG, KH, KN, (22) International Filing Date: KP, KR, KW, KZ, LA, LC, LK, LR, LS, LU, LY, MA, 15 February 2017 (15.02.2017) MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, (25) Filing Language: English RU, RW, SA, SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, (26) Publication Language: English TH, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. (30) Priority Data: 62/298,657 23 February 2016 (23.02.2016) US (84) Designated States (unless otherwise indicated, for every kind of regional protection available): ARIPO (BW, GH, (71) Applicant: PFIZER INC. [US/US]; 235 East 42nd Street, GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, ST, SZ, New York, New York 10017 (US).
  • Metabolism and Pharmacokinetics in the Development of New Therapeutics for Cocaine and Opioid Abuse

    Metabolism and Pharmacokinetics in the Development of New Therapeutics for Cocaine and Opioid Abuse

    University of Mississippi eGrove Electronic Theses and Dissertations Graduate School 2012 Metabolism And Pharmacokinetics In The Development Of New Therapeutics For Cocaine And Opioid Abuse Pradeep Kumar Vuppala University of Mississippi Follow this and additional works at: https://egrove.olemiss.edu/etd Part of the Pharmacy and Pharmaceutical Sciences Commons Recommended Citation Vuppala, Pradeep Kumar, "Metabolism And Pharmacokinetics In The Development Of New Therapeutics For Cocaine And Opioid Abuse" (2012). Electronic Theses and Dissertations. 731. https://egrove.olemiss.edu/etd/731 This Dissertation is brought to you for free and open access by the Graduate School at eGrove. It has been accepted for inclusion in Electronic Theses and Dissertations by an authorized administrator of eGrove. For more information, please contact [email protected]. METABOLISM AND PHARMACOKINETICS IN THE DEVELOPMENT OF NEW THERAPEUTICS FOR COCAINE AND OPIOID ABUSE A Dissertation presented in partial fulfillment of requirements for the degree of Doctor of Philosophy in Pharmaceutical Sciences in the Department of Pharmaceutics The University of Mississippi by PRADEEP KUMAR VUPPALA April 2012 Copyright © 2012 by Pradeep Kumar Vuppala All rights reserved ABSTRACT Cocaine and opioid abuse are a major public health concern and the cause of significant morbidity and mortality worldwide. The development of effective medication for cocaine and opioid abuse is necessary to reduce the impact of this issue upon the individual and society. The pharmacologic treatment for drug abuse has been based on one of the following strategies: agonist substitution, antagonist treatment, or symptomatic treatment. This dissertation is focused on the role of metabolism and pharmacokinetics in the development of new pharmacotherapies, CM304 (sigma-1 receptor antagonist), mitragynine and 7-hydroxymitragynine (µ-opioid receptor agonists), for the treatment of drug abuse.
  • Development and Validation of an Ultra-Fast and Sensitive Microflow

    Development and Validation of an Ultra-Fast and Sensitive Microflow

    Drug Testing Research article and Analysis Received: 6 June 2016 Revised: 9 July 2016 Accepted: 10 July 2016 Published online in Wiley Online Library: 10 August 2016 (www.drugtestinganalysis.com) DOI 10.1002/dta.2042 Development and validation of an ultra-fast and sensitive microflow liquid chromatography- tandem mass spectrometry (MFLC-MS/MS) method for quantification of LSD and its metabolites in plasma and application to a controlled LSD administration study in humans Andrea E. Steuer,a* Michael Poetzsch,a Lorena Stock,a Lisa Eisenbeiss,a Yasmin Schmid,b Matthias E. Liechtib and Thomas Kraemera Lysergic acid diethylamide (LSD) is a semi-synthetic hallucinogen that has gained popularity as a recreational drug and has been investigated as an adjunct to psychotherapy. Analysis of LSD represents a major challenge in forensic toxicology due to its insta- bility, low drug concentrations, and short detection windows in biological samples. A new, fast, and sensitive microflow liquid chromatography (MFLC) tandem mass spectrometry method for the validated quantification of LSD, iso-LSD, 2-oxo 3-hydroxy- LSD (oxo-HO-LSD), and N-desmethyl-LSD (nor-LSD) was developed in plasma and applied to a controlled pharmacokinetic (PK) study in humans to test whether LSD metabolites would offer for longer detection windows. Five hundred microlitres of plasma were extracted by solid phase extraction. Analysis was performed on a Sciex Eksigent MFLC system coupled to a Sciex 5500 QTrap. The method was validated according to (inter)-national guidelines. MFLC allowed for separation of the mentioned analytes within 3 minutes and limits of quantification of 0.01 ng/mL.
  • A Role for Histone Modification in the Mechanism of Action of Antidepressant and Stimulant Drugs: a Dissertation

    A Role for Histone Modification in the Mechanism of Action of Antidepressant and Stimulant Drugs: a Dissertation

    University of Massachusetts Medical School eScholarship@UMMS GSBS Dissertations and Theses Graduate School of Biomedical Sciences 2007-12-28 A Role for Histone Modification in the Mechanism of Action of Antidepressant and Stimulant Drugs: a Dissertation Frederick Albert Schroeder University of Massachusetts Medical School Let us know how access to this document benefits ou.y Follow this and additional works at: https://escholarship.umassmed.edu/gsbs_diss Part of the Amino Acids, Peptides, and Proteins Commons, Cells Commons, Enzymes and Coenzymes Commons, Genetic Phenomena Commons, Mental Disorders Commons, Nervous System Commons, and the Therapeutics Commons Repository Citation Schroeder FA. (2007). A Role for Histone Modification in the Mechanism of Action of Antidepressant and Stimulant Drugs: a Dissertation. GSBS Dissertations and Theses. https://doi.org/10.13028/7bk0-a687. Retrieved from https://escholarship.umassmed.edu/gsbs_diss/370 This material is brought to you by eScholarship@UMMS. It has been accepted for inclusion in GSBS Dissertations and Theses by an authorized administrator of eScholarship@UMMS. For more information, please contact [email protected]. A Dissertation Presented by Frederick Albert Schroeder Submitted to the Faculty of the University of Massachusetts Graduate School of Biomedical Sciences Worcester, Massachusetts, USA in partial fulfillment of the requirements for the degree of DOCTOR OF PHILOSOPHY December 28, 2007 Program in Neuroscience A Role for Histone Modification in the Mechanism of Action of Antidepressant and Stimulant Drugs A Dissertation Presented By Frederick Albert Schroeder Approved as to style and content by: _____________________________________ Alonzo Ross, Ph.D., Chair of Committee _____________________________________ Pradeep Bhide, Ph.D., Member of Committee _____________________________________ Craig L.
  • Around the Corner Canadian Equity Research Emerging Companies and Industries to Watch 3 March 2020

    Around the Corner Canadian Equity Research Emerging Companies and Industries to Watch 3 March 2020

    Around the Corner Canadian Equity Research Emerging companies and industries to watch 3 March 2020 Tania Gonsalves, CFA | Analyst | Canaccord Genuity Corp. (Canada) | [email protected] | 1.416.996.8346 Scott McFarland | Associate | Canaccord Genuity Corp. (Canada) | [email protected] | 1.416.998.7202 Around the Corner highlights what we believe are some of the most exciting Psychedelic-derived medicines and therapies emergent private companies in Canada, and/or industry themes and trends which are yet to be fully represented in the Mental health miracle or another bad trip? public markets. When most of us think of psychedelic drugs, we think of the 1960s counterculture. We We aim to offer insight into early industry think of anti-establishment, anti-war, anti-capitalist hippies, Woodstock, tie-dye, Lucy in trends, educate investors about private the Sky, peace, love and bell bottom jeans. But before psychedelics became ingrained in companies that are making a mark, and the counterculture, they were found in a lab. The first wave of scientific research on identify companies that may enter the psychedelics took place between 1950-65. Sandoz Pharmaceutics, what is now Novartis public markets in the future. AG (NVS-NYSE), the third largest pharmaceutical company in the world, used to market We do not provide any ratings or price LSD and psilocybin for psychotherapeutic purposes. Psychedelics weren’t born of the targets, nor should any be inferred, for counterculture. They were killed by it. The proliferation of recreational use spurred any uncovered company featured in government intervention and by 1971, psilocybin, LSD, ibogaine, mescaline, peyote, Around the Corner.
  • Stability Study of Cannabidiol in the Form of Solid Powder and Sunflower Oil Solution

    Stability Study of Cannabidiol in the Form of Solid Powder and Sunflower Oil Solution

    pharmaceutics Article Stability Study of Cannabidiol in the Form of Solid Powder and Sunflower Oil Solution Ema Kosovi´c 1,2 , David Sýkora 2 and Martin Kuchaˇr 3,* 1 Institute of Chemical Process Fundamentals of CAS v.v.i., Rozvojová 135, 16502 Prague, Czech Republic; [email protected] 2 Department of Analytical Chemistry, University of Chemistry and Technology Prague, Technická 5, 16628 Prague, Czech Republic; [email protected] 3 Forensic Laboratory of Biologically Active Substances, Department of Chemistry of Natural Compounds, University of Chemistry and Technology Prague, Technická 5, 16628 Prague, Czech Republic * Correspondence: [email protected] Abstract: Stability studies represent an essential component of pharmaceutical development, en- abling critical evaluation of the therapeutic potential of an active pharmaceutical ingredient (API) or a final pharmaceutical product under the influence of various environmental factors. The aim of the present study was to investigate the chemical stability of cannabidiol (CBD) in the form of a solid powder (hereinafter referred to as CBD powder) and also dissolved in sunflower oil. We performed stress studies in accordance with the International Conference on Harmonization (ICH) guidelines, where 5 mg of marketed CBD in the form of a solid powder and in form of oil solution were exposed for 7 and 14, 30, 60, 90, 180, 270, and 365 days to precisely defined temperature and humidity conditions, 25 ◦C ± 2 ◦C/60% RH ± 5% and 40 ◦C ± 2 ◦C/75% RH ± 5% in both open and closed vials in the dark. CBD powder was significantly more stable than CBD in oil solution. Such finding is important because CBD is often administered dissolved in oil matrix in practice due to Citation: Kosovi´c,E.; Sýkora, D.; very good bioavailability.
  • Endocannabinoid Stimulated Release of Nitric Oxide and Its Mitochondrial

    Endocannabinoid Stimulated Release of Nitric Oxide and Its Mitochondrial

    A tica nal eu yt c ic a a m A r a c t Stefano et al., Pharm Anal Acta 2015, 6:6 h a P Pharmaceutica Analytica Acta DOI: 10.4172/2153-2435.1000378 ISSN: 2153-2435 Review Article Open Access Endocannabinoid Stimulated Release of Nitric Oxide and its Mitochondrial Influence Triggering Vascular Pathology George B Stefano*, Erin Quinn and Richard M Kream MitoGenetics LLC, 3 Bioscience Park Drive, Suite 307, Farmingdale, NY 11735, USA Abstract Endocannabinoids, and their respective receptors, are involved in a host of cellular regulatory activities. In part, some of these mediated effects occur by way of stimulating constitutive nitric oxide release. This occurs in endothelia, certain white blood cells, microglia, and in similar invertebrate tissues, demonstrating that this is a conserved chemical messenger system. This endocannabinoid chemical messenger system, coupled to constitutive nitric oxide release, also appears to exert regulatory effects on mitochondrial energy associated processes, further substantiating its primordial history. In this regard, it appears to offer some beneficial actions in the occurrence of reperfusion injury and stroke. The mechanism envisioned is one initiated via a hypoxic event, which does not restore normalcy, then progresses to a pro-inflammatory state, and the resultant chronic condition manifests itself in a specific disorder. This fits nicely into a vascular-associated origin for Alzheimer’s Disease, whereby the pro- inflammatory state encompasses vessels that have endothelial gaps, providing for a compromised blood brain barrier, beta amyloid deposition, and enhanced white blood cell trafficking. In time, due to the physical progression of the events, Alzheimer’s Disease occurs.
  • G Protein-Coupled Receptors

    G Protein-Coupled Receptors

    S.P.H. Alexander et al. The Concise Guide to PHARMACOLOGY 2015/16: G protein-coupled receptors. British Journal of Pharmacology (2015) 172, 5744–5869 THE CONCISE GUIDE TO PHARMACOLOGY 2015/16: G protein-coupled receptors Stephen PH Alexander1, Anthony P Davenport2, Eamonn Kelly3, Neil Marrion3, John A Peters4, Helen E Benson5, Elena Faccenda5, Adam J Pawson5, Joanna L Sharman5, Christopher Southan5, Jamie A Davies5 and CGTP Collaborators 1School of Biomedical Sciences, University of Nottingham Medical School, Nottingham, NG7 2UH, UK, 2Clinical Pharmacology Unit, University of Cambridge, Cambridge, CB2 0QQ, UK, 3School of Physiology and Pharmacology, University of Bristol, Bristol, BS8 1TD, UK, 4Neuroscience Division, Medical Education Institute, Ninewells Hospital and Medical School, University of Dundee, Dundee, DD1 9SY, UK, 5Centre for Integrative Physiology, University of Edinburgh, Edinburgh, EH8 9XD, UK Abstract The Concise Guide to PHARMACOLOGY 2015/16 provides concise overviews of the key properties of over 1750 human drug targets with their pharmacology, plus links to an open access knowledgebase of drug targets and their ligands (www.guidetopharmacology.org), which provides more detailed views of target and ligand properties. The full contents can be found at http://onlinelibrary.wiley.com/doi/ 10.1111/bph.13348/full. G protein-coupled receptors are one of the eight major pharmacological targets into which the Guide is divided, with the others being: ligand-gated ion channels, voltage-gated ion channels, other ion channels, nuclear hormone receptors, catalytic receptors, enzymes and transporters. These are presented with nomenclature guidance and summary information on the best available pharmacological tools, alongside key references and suggestions for further reading.
  • The Use of Stems in the Selection of International Nonproprietary Names (INN) for Pharmaceutical Substances

    The Use of Stems in the Selection of International Nonproprietary Names (INN) for Pharmaceutical Substances

    WHO/PSM/QSM/2006.3 The use of stems in the selection of International Nonproprietary Names (INN) for pharmaceutical substances 2006 Programme on International Nonproprietary Names (INN) Quality Assurance and Safety: Medicines Medicines Policy and Standards The use of stems in the selection of International Nonproprietary Names (INN) for pharmaceutical substances FORMER DOCUMENT NUMBER: WHO/PHARM S/NOM 15 © World Health Organization 2006 All rights reserved. Publications of the World Health Organization can be obtained from WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel.: +41 22 791 3264; fax: +41 22 791 4857; e-mail: [email protected]). Requests for permission to reproduce or translate WHO publications – whether for sale or for noncommercial distribution – should be addressed to WHO Press, at the above address (fax: +41 22 791 4806; e-mail: [email protected]). The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters.
  • FDA Regulation of Cannabidiol (CBD) Products

    FDA Regulation of Cannabidiol (CBD) Products

    June 12, 2019 FDA Regulation of Cannabidiol (CBD) Products Cannabidiol (CBD) is promoted as treatment for a range of and hemp-derived compounds, including CBD. However, conditions, including epileptic seizures, post-traumatic the farm bill explicitly preserved FDA’s authority under the stress disorder, anxiety, and inflammation—despite limited Federal Food, Drug and Cosmetic Act (FFDCA, 21 U.S.C. scientific evidence to substantiate many of these claims. In §§301 et seq.) and Section 351 of the Public Health Service the United States, CBD is marketed in food and beverages, Act (PHSA, 42 U.S.C. §262), including for hemp-derived dietary supplements, and cosmetics—products that are products. According to FDA, “because the 2018 Farm Bill regulated by the Food and Drug Administration (FDA). did not change FDA’s authorities, cannabis and cannabis- CBD is also the active ingredient in an FDA-approved pharmaceutical drug, Epidiolex®. CBD is a plant-derived derived products are subject to the same authorities and substance from Cannabis sativa, the species of plant that requirements as FDA-regulated products containing any includes both hemp and marijuana, but from different plant other substance, regardless of whether the products fall varieties or cultivars. CBD is the primary nonpsychoactive within the definition of ‘hemp’ under the 2018 Farm Bill.” compound in cannabis, whereas tetrahydrocannabinol (THC) is cannabis’s primary psychoactive compound. FDA Regulation of CBD Products FDA, under the FFDCA, regulates many of the products Regulation of CBD Products marketed as containing cannabis and cannabis-derived Hemp and marijuana have separate definitions in U.S. law compounds, including CBD.
  • Responding to an Urgent Mental Health Crisis Challenges and Solutions for People Suffering with Treatment-Resistant Depression

    Responding to an Urgent Mental Health Crisis Challenges and Solutions for People Suffering with Treatment-Resistant Depression

    Responding to an urgent mental health crisis Challenges and solutions for people suffering with treatment-resistant depression A White Paper from COMPASS Pathways August 2021 Contents Foreword from George Goldsmith ..............................................................................................................03 Introduction ........................................................................................................................................................05 Executive summary . .........................................................................................................................................06 Part I: Treatment-resistant depression - background and challenges .................................................08 o Mental health disorders o Depression: an overview o Major depressive disorder and treatment-resistant depression o Suicide and treatment-resistant depression o Mental health care spending and use of services Part II: Current approaches and limitations for treatment of depression ...........................................15 o A fragmented and inaccessible mental health care system o Treatment approaches for depression o Psychotherapy o Drug therapy o Physical (somatic) therapies o Lack of research and development for new drug treatments Part III: Emerging solutions in treatments for depression ......................................................................24 o Emerging treatment options and the challenges of getting these to patients o Psychedelic therapies: a new frontier
  • Psilocybin-Assisted Psychotherapy: Treating Depression and Anxiety with Mushrooms

    Psilocybin-Assisted Psychotherapy: Treating Depression and Anxiety with Mushrooms

    Dominican Scholar Physician Assistant Studies | Student Department of Physician Assistant Articles Studies 2020 Psilocybin-Assisted Psychotherapy: Treating Depression and Anxiety with Mushrooms Sofia Beck Dominican University of California https://doi.org/10.33015/dominican.edu/2020.PAS.10 Survey: Let us know how this paper benefits you. Recommended Citation Beck, Sofia, "Psilocybin-Assisted Psychotherapy: Treating Depression and Anxiety with Mushrooms" (2020). Physician Assistant Studies | Student Articles. 7. https://doi.org/10.33015/dominican.edu/2020.PAS.10 This Article is brought to you for free and open access by the Department of Physician Assistant Studies at Dominican Scholar. It has been accepted for inclusion in Physician Assistant Studies | Student Articles by an authorized administrator of Dominican Scholar. For more information, please contact [email protected]. ABSTRACT Depression and anxiety are debilitating mental health conditions that affect a large portion of the United States. Current pharmacological treatments for these disorders require daily administration, are associated with a number of side effects, and can be ineffective for some. Emerging evidence in novel treatment options may necessitate a shift toward how we treat these psychiatric disorders. Studies involving the psychedelic serotonin agonist, psilocybin, are currently experiencing a resurgence as an alternative for patients who are unresponsive to traditional treatments. Clinical trials using psilocybin in combination with psychotherapy have demonstrated sustained reductions in depression and/or anxiety symptoms. When used in medical settings, it has shown to be safe, with few side effects and no risk of dependence. However, this psychedelic compound faces many stigmas and these results have yet to be compared to current treatments or in larger populations.