−Removed: This Annual Report on Form 10-K contains
−Removed: forward-looking statements based on expectations, estimates, and projections as of the date of this filing.
−Removed: Actual results may
−Removed: differ materially from those expressed in forward-looking statements.
−Removed: See Item 1A of Part I—“Risk Factors.”
−Removed: Odyssey Group International, Inc.
−Removed: as a Nevada corporation in March 2014.
−Removed: Our principal executive offices are located at 2372 Morse Ave., Irvine, CA 92614.
−Removed: The registration
−Removed: statement effectuating our initial public offering became effective in July 2015.
−Removed: Currently our shares of common stock are
−Removed: listed on the Over the Counter (OTC) exchange and there is currently very little public market for our common stock.
−Removed: the process of applying for quotation on the OTC Electronic Bulletin Board, known as the OTCQB.
−Removed: As used herein, when we refer to “Odyssey”,
−Removed: “ODYY,”
+Added: This Annual Report
+Added: on Form 10-K contains forward-looking statements based on expectations, estimates, and projections as of the date of this filing.
+Added: Actual results may differ materially from those expressed in forward-looking statements.
+Added: See Item 1A of Part I—“Risk
+Added: Factors.”
+Added: Odyssey Group International,
+Added: was formed as a Nevada corporation in March 2014.
+Added: Our principal executive offices are located at 2372 Morse Ave., Irvine,
+Added: The registration statement effectuating our initial public offering became effective in July 2015.
+Added: Our shares of common
+Added: stock are listed on the OTCQB Marketplace (“OTC”) and there is currently very little public market for our common stock.
+Added: As used herein, when
+Added: we refer to “Odyssey”, “ODYY,”
the “Company,”
3 unchanged sentences
and “our,”
−Removed: we mean Odyssey Group International, Inc., a Nevada corporation, unless the context indicates otherwise.
−Removed: Recently the United States Congress passed
−Removed: the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”), which provides for certain exemptions from various
−Removed: reporting requirements applicable to public companies that are reporting companies and are “emerging growth companies.”
+Added: we mean Odyssey Group International, Inc., a Nevada corporation, unless the context indicates
+Added: Recently the United
+Added: States Congress passed the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”), which provides for certain
+Added: exemptions from various reporting requirements applicable to public companies that are reporting companies and are “emerging
+Added: growth companies.”
We are an “emerging growth company”
−Removed: as defined in Section 3(a) of the Exchange Act (as amended by the JOBS Act, enacted
−Removed: on April 5, 2012), and we will continue to qualify as an “emerging growth company”
−Removed: until the earliest to occur of:
−Removed: (a) the last day of the fiscal year during which we have total annual gross revenues of $1,000,000,000 (as such amount is indexed
−Removed: for inflation every five years by the SEC) or more;
−Removed: (b) the last day of our fiscal year following the fifth anniversary of the
−Removed: date of the first sale of our common equity securities pursuant to an effective registration statement under the Securities Act;
−Removed: (c) the date on which we have, during the previous three-year period, issued more than $1,000,000,000 in non-convertible debt;
+Added: as defined in Section 3(a) of the Exchange Act (as amended
+Added: by the JOBS Act, enacted on April 5, 2012), and we will continue to qualify as an “emerging growth company”
+Added: earliest to occur of:
+Added: (a) the last day of the fiscal year during which we have total annual gross revenues of $1,000,000,000 (as
+Added: such amount is indexed for inflation every five years by the SEC) or more;
+Added: (b) the last day of our fiscal year following the fifth
+Added: anniversary of the date of the first sale of our common equity securities pursuant to an effective registration statement under
+Added: the Securities Act;
+Added: (c) the date on which we have, during the previous three-year period, issued more than $1,000,000,000 in non-convertible
or (d) the date on which we are deemed to be a “large accelerated filer,”
as defined in Exchange Act Rule 12b–2.
−Removed: Therefore, we expect to continue to be an emerging growth company for the foreseeable future.
−Removed: Generally, a registrant that registers any
−Removed: class of its securities under Section 12 of the Exchange Act is required to include in the second and all subsequent annual reports
−Removed: filed by it under the Exchange Act a management report on internal control over financial reporting and, subject to an exemption
−Removed: available to registrants that meet the definition of a “smaller reporting company”
−Removed: in Exchange Act Rule 12b-2, an auditor
−Removed: attestation report on management’s assessment of internal control over financial reporting.
−Removed: However, for so long as we continue
−Removed: to qualify as an emerging growth company, we will be exempt from the requirement to include an auditor attestation report in our
−Removed: annual reports filed under the Exchange Act, even if we do not qualify as a “smaller reporting company”.
−Removed: as an emerging growth company, we are able to avail ourselves to the reduced disclosure obligations regarding executive compensation
−Removed: in our periodic reports and proxy statements and not to present to our stockholders a nonbinding advisory vote on executive compensation,
−Removed: obtain approval of any golden parachute payments not previously approved or present the relationship between executive compensation
−Removed: actually paid and our financial performance.
−Removed: We have irrevocably elected to comply with new or revised accounting standards even
−Removed: though we are an emerging growth company.
−Removed: Odyssey Group International, Inc.
−Removed: (“Odyssey”
−Removed: or “the Company”), was formed as a publicly held holding company with an emphasis on the development and acquisition
−Removed: of medical products and health related technologies.
−Removed: The Company is focused on building and acquiring assets in areas that have
−Removed: an identified technological advantage and a substantial market opportunity within significant target markets across the globe.
−Removed: The corporate mission is to create or acquire
−Removed: distinct assets, intellectual property, and technologies with an emphasis on acquisition targets that will generate positive cash
−Removed: Our strategic mission is to deliver financial results, which yield high rates of returns for our shareholders and partners.
−Removed: The Company’s leadership team has significant experience and capabilities to further refine the technologies and submit to
−Removed: the appropriate regulatory agencies for marketing approval.
−Removed: We engaged The Center for Valuation Studies (“CFVS”) to
−Removed: assist in estimating the fair market value of the assets of the Company for general corporate purposes.
−Removed: To derive an estimate of
−Removed: fair market value of the assets, CFVS relied on the information provided by management.
−Removed: Our business model is to develop or acquire
−Removed: medical related products, engage third parties to manufacture such products and then distribute the products through various distribution
−Removed: channels, including third parties.
−Removed: The Company has significant assets in three different life saving technologies;
+Added: Generally, a registrant
+Added: that registers any class of its securities under Section 12 of the Exchange Act is required to include in the second and all subsequent
+Added: annual reports filed by it under the Exchange Act a management report on internal control over financial reporting and, subject
+Added: to an exemption available to registrants that meet the definition of a “smaller reporting company”
+Added: in Exchange Act
+Added: Rule 12b-2, an auditor attestation report on management’s assessment of internal control over financial reporting.
+Added: for so long as we continue to qualify as an emerging growth company, we will be exempt from the requirement to include an auditor
+Added: attestation report in our annual reports filed under the Exchange Act, even if we do not qualify as a “smaller reporting
+Added: company”.
+Added: In addition, as an emerging growth company, we are able to avail ourselves to the reduced disclosure obligations
+Added: regarding executive compensation in our periodic reports and proxy statements and not to present to our stockholders a nonbinding
+Added: advisory vote on executive compensation, obtain approval of any golden parachute payments not previously approved or present the
+Added: relationship between executive compensation actually paid and our financial performance.
+Added: We have irrevocably elected to comply
+Added: with new or revised accounting standards even though we are an emerging growth company.
+Added: Odyssey was formed
+Added: as a publicly held holding company with an emphasis on the development and acquisition of medical products and health related technologies.
+Added: We are focused on building and acquiring technologies that have a technological advantage and a substantial market opportunity
+Added: within significant target markets across the globe.
+Added: The corporate mission is to create or acquire distinct technologies and intellectual
+Added: property with an emphasis on acquisition targets that will generate positive cash flow.
+Added: Our strategic mission is to deliver financial
+Added: results, which yield high rates of returns for our shareholders and partners.
+Added: The Company’s leadership team has significant
+Added: experience and capabilities to further refine the technologies and submit to the appropriate regulatory agencies for marketing
+Added: Our business model
+Added: is to develop or acquire medical related products, engage third parties to manufacture such products and then distribute the products
+Added: through various distribution channels, including third parties.
+Added: The Company has product development projects in three different
+Added: life saving technologies;
the CardioMap®
−Removed: heart monitoring and screening device, the Save A Life choking rescue device and a unique neurosteroid drug compound intended to
−Removed: treat rare brain disorders.
−Removed: We intend to acquire other technologies
−Removed: and assets and plan to be a trans-disciplinary product development company involved in the discovery, development and commercialization
−Removed: of products and technologies that may be applied over various medical markets.
−Removed: We intend to license, improve and/or develop
−Removed: our products and identify and select distribution channels.
−Removed: We intend to establish agreements with distributors to get products
−Removed: to market quickly as well as to undertake and engage in our own direct marketing efforts.
−Removed: We will determine the most effective
−Removed: method of distribution for each unique product that we include in our portfolio.
−Removed: We intend to engage third party research
−Removed: and development firms who specialize in the creation of medical products to assist us in the development.
−Removed: We intend to apply for
−Removed: trademarks and patents as we develop proprietary products.
−Removed: Financial Information about Industry Segments
−Removed: We do not report our revenues or expenses
+Added: heart monitoring and screening device, the Save A Life choking rescue device and a
+Added: unique neurosteroid drug compound intended to treat rare brain disorders.
+Added: We intend to acquire
+Added: other technologies and assets and plan to be a multi-disciplinary product development company involved in the discovery, development
+Added: and commercialization of products and technologies that may be applied over various medical markets.
+Added: We intend to license,
+Added: improve and/or develop our products and identify and select distribution channels.
+Added: We intend to establish agreements with distributors
+Added: to get products to market quickly as well as to undertake and engage in our own direct marketing efforts.
+Added: We will determine the
+Added: most effective method of distribution for each unique product that we include in our portfolio.
+Added: We intend to engage
+Added: third party research and development firms who specialize in the creation of medical products to assist us in the development.
+Added: We intend to apply for trademarks and patents as we develop proprietary products.
+Added: For a complete description
+Added: of our business, financial condition, results of operations and other important information, we refer you to our filings with the
+Added: SEC that are incorporated by reference in this Annual Report, including our Annual
+Added: Report on Form 10-K for the year ended July 31, 2019 and our Quarterly
+Added: Reports on Form 10-Q for the periods ended October 31, 2019, January 31, 2020 and April 30, 2020, as amended by the filings
+Added: of Form 10K/A for the period ended July 31, 2019 and Quarterly Reports on Form 10-Q/A for the periods ended October 31, 2019, January
+Added: 31, 2020 and April 30, 2020 filed and with the Securities and Exchange Commission on November 13, 2020.
+Added: For instructions on how
+Added: to find copies of these documents, see the section entitled “Where You Can Find More Information”.
+Added: Financial Information about Industry
+Added: We do not report our
+Added: revenues or expenses by segment.
See financial statements.
1 unchanged sentence
Once the U.S.
−Removed: Food and Drug Administration
−Removed: (the “FDA”) clears us to market the CardioMap®
−Removed: and Save a Life products, we intend to enter into agreements with
−Removed: qualified distributors throughout the United States and world, including:
−Removed: Europe, South America, Africa, India and China.
−Removed: to require such distributors to pay to our company an initial license fee as well as royalties based on gross sales.
−Removed: exclusivity, we will bill based on a mutually agreeable semi-annual or quarterly sales minimum.
−Removed: We have determined to focus on
−Removed: international growth because generally such international license agreements provide a stronger path to revenue and earnings than
−Removed: purely domestic products.
−Removed: Our objective is to grow revenue through
−Removed: marketing and sales of each of our current products, CardioMap®
−Removed: and Save a Life.
−Removed: Although no assurances can be given, management
−Removed: anticipates company growth from the following areas:
+Added: and Drug Administration (the “FDA”) clears us to market the CardioMap®
+Added: and Save a Life products, we intend to enter
+Added: into agreements with qualified distributors throughout the United States and internationally, including:
+Added: Europe, South America,
+Added: Africa, India and China.
+Added: We intend to require such distributors to pay us an initial license fee, as well as royalties based on
+Added: Retaining exclusivity, we will bill based on a mutually agreeable semi-annual or quarterly sales minimum.
+Added: determined to focus on international growth because, generally, such international license agreements provide a stronger path to
+Added: revenue and earnings than purely domestic products.
+Added: Our objective is to
+Added: grow revenue through marketing and sales of each of our products, CardioMap®
+Added: and Save a Life, once they gain regulatory approvals.
+Added: Although no assurances can be given, management anticipates company growth from the following areas:
Distribution or License Agreements.
−Removed: In most cases, we will enter into distribution agreements with companies who already have sales professionals that already have experience selling through a variety of sales methods.
+Added: In most cases, we will enter into distribution agreements with companies who have sales professionals with experience selling through a variety of sales methods.
These distribution agreements will allow us to more quickly achieve sales and revenue in the health products industries.
5 unchanged sentences
for additional proprietary uses of the product.
−Removed: We intend to identify and find new areas of the human body to map utilizing CardioMap®
+Added: We intend to identify new areas of the human body to map utilizing CardioMap®
technology such as the brain, liver and kidney.
1 unchanged sentence
We intend to market any new products that may be developed or acquired.
−Removed: We intend to, as capital resources permit, develop such opportunities if and when they present themselves.
+Added: We intend, as capital resources permit, to develop such opportunities if and when they present themselves.
About CardioMap®
−Removed: CardioMap®
−Removed: System will be an internet service based on the new development of Dispersion Mapping Method
−Removed: in ECG analysis for the early, non-invasive testing of coronary heart disease (CHD).
−Removed: The heart monitoring system is in a prototype
−Removed: stage and will provide high quality 3-D visualization and diagnosis of the heart using advanced signal analysis.
−Removed: The Company owns technology and the marketing
−Removed: and distribution rights related to CardioMap®.
−Removed: CardioMap®
−Removed: measures disease or stress levels, along with current heart conditions
−Removed: as a 3D image supplementing the line drawing electrocardiogram (ECG), but with device sensitivity that surpasses standard ECG analyzers.
−Removed: It is highly portable and provides a rapid analysis in 30 or 60 seconds.
−Removed: The device is connected through the Internet to the central
−Removed: server that converts the electric conductivity of the cardiac tissue into a three-dimensional, color-coded and easy-to-interpret
−Removed: visual portrait.
The CardioMap®
−Removed: is in advanced prototype stages of development and is not yet cleared by the FDA.
+Added: System will be an internet service based on the new development of Dispersion Mapping Method in ECG analysis for the
+Added: early, non-invasive testing of a heart disease (“CHD”).
+Added: The heart monitoring system is intended to provide high quality
+Added: 3-D visualization and diagnosis of the heart using advanced signal analysis.
+Added: The product is being designed for use in a professional
+Added: setting or in remote settings including home use.
Once FDA cleared, CardioMap®
−Removed: could provide
−Removed: a better level of diagnosis with its improved sensitivity levels that can detect early warning signs that would normally be invisible
−Removed: with standard ECG devices.
−Removed: The system can dramatically cut the costs associated with the detection of ischemic heart disease and
−Removed: could prove to be an invaluable testing device for cardiologists, physicians, clinics, hospitals, the fitness industry, sports
−Removed: teams, emergency facilities and general public.
+Added: could provide a better level of diagnosis with its improved sensitivity levels that can detect early warning signs that would normally
+Added: be invisible with standard ECG devices.
+Added: The system is designed to dramatically cut the costs associated with the detection of ischemic
+Added: heart disease and will prove to be an invaluable testing device for cardiologists, physicians, clinics, hospitals, the fitness
+Added: industry, sports teams, emergency facilities and general public.
CardioMap®
−Removed: was developed by VE Science Technology LLC, from whom we have purchased
−Removed: the product rights.
−Removed: About Save a Life Choking Rescue
−Removed: On June 27, 2019, Odyssey entered into a
−Removed: Definitive Agreement with Dr.
−Removed: James De Luca (“De Luca”), inventor and Murdock Capital Partners (“MCP”),
−Removed: advisors to De Luca, to acquire the intellectual property, know-how and patents for a life-saving medical device currently in development.
−Removed: The Company acquired intellectual property rights, namely, United States Letters Patent No.
−Removed: 7,559,921, entitled “Device for
−Removed: Removing a Lodged Mass”
−Removed: which issued on July 14, 2009 and which was reissued on June 2, 2015 and received U.S.
−Removed: Reissue Patent
−Removed: Re 45,535 and United States Patent Number 8,454,624 also entitled “Device for Removing a Lodged Mass”
−Removed: issued on June 4, 2013.
−Removed: As consideration for the patent and intellectual
−Removed: property, the Company granted stock options totaling 600,000 shares of the Company’s stock, vesting on certain milestones.
−Removed: The options will be split between De Luca and MCP.
−Removed: The Company also granted Dr.
−Removed: De Luca, 20,000 common shares of stock.
−Removed: Upon commercial
−Removed: sales of the product, the Company will also pay a three percent (3%) royalty on the net profit of each device sold, once it is
−Removed: approved by all necessary regulatory bodies.
−Removed: The Save a Life (“SAL”)
−Removed: Choking Rescue Device will be the only FDA cleared device that uses a patented “Negative Pressure”
−Removed: design to dislodge
−Removed: objects from the throat.
−Removed: It is an instantaneous, one step action that anyone can operate.
−Removed: A working prototype has been tested successfully
−Removed: A development program for further refining the design and submitting for FDA clearance has been created.
−Removed: In June 2019,
−Removed: the Company acquired the issued patents number RE45, 535 E and patent number 8,454,624 B2 for the choking rescue device.
−Removed: The Company believes its choking rescue
−Removed: device will quickly become the “accepted”
−Removed: standard and leader in the treatment of choking incidents globally.
−Removed: The Company’s
−Removed: device is designed to quickly, safely and economically address a medical situation that occurs often, is indiscriminate of time
−Removed: and place, is complex, time-sensitive, and if treated incorrectly can cause unintended or unexpected injury and even death.
−Removed: The Save a Life choking rescue device
−Removed: is a patented, safe, and easy to use for removing a lodged mass or bolus from the throat of a choking victim.
−Removed: The device includes
−Removed: a pump for creating a vacuum chamber which is connected seamlessly with a replaceable/disposable mouthpiece.
−Removed: In an emergency the
−Removed: SAL may be easily inserted into the victim’s mouth which depresses the tongue providing a clear, trauma-free application.
−Removed: By pressing a button on the device, the device will deliver the appropriate amount of instantaneous vacuum to dislodge the mass
−Removed: or bolus in the throat without harm or damage to the victim.
−Removed: The application is instantly effective as the device is operational
−Removed: and effective in a matter of seconds.
−Removed: The Save a Life has a number of advantages
−Removed: and features.
+Added: was developed by VE Science Technology LLC, from
+Added: whom we have purchased the product rights.
+Added: In order to sell, market and distribute the CardioMap®
+Added: product, clearance from the
+Added: FDA is required.
+Added: Such clearance has not been obtained at this time.
+Added: Product Development
+Added: Engineering Model
+Added: Clinical Trial
+Added: FDA Submission
+Added: The product development
+Added: plan is an estimate and is subject to change based on funding, technical risks and regulatory approvals.
+Added: About Save-a-Life®
+Added: The Save a Life®
+Added: (“SAL”) choking rescue device is in development and being designed to be a safe, and easy to use device for removing
+Added: a lodged mass or bolus from the throat of a choking victim.
+Added: The device includes a pump for creating a vacuum chamber, which is
+Added: connected seamlessly with a replaceable/disposable mouthpiece.
+Added: In an emergency the SAL may be easily inserted into the victim’s
+Added: mouth, which depresses the tongue providing a clear application.
+Added: By pressing a button on the device, the device will deliver the
+Added: appropriate amount of instantaneous vacuum to dislodge the mass or bolus in the throat without harm or damage to the victim.
+Added: application will be instantly effective as the device is operational and effective in a matter of seconds.
+Added: In order to sell, market
+Added: and distribute the Save-a-Life product, clearance from the FDA is required.
+Added: Such clearance has not been obtained at this time.
+Added: The Development Plan for commercializing the Save-a-Life product is below.
+Added: Product Development
+Added: Engineering Model
+Added: Clinical Trial
+Added: FDA Submission
+Added: Complete –
+Added: in testing phase
+Added: Product development
+Added: plan are estimates only and are subject to change based on funding, technical risks and regulatory approvals.
+Added: The Save a Life
+Added: has a number of advantages and features.
The highlights are:
1 unchanged sentence
The product is designed to be used by adults and children.
−Removed: The tongue depressor vacuum tube is inserted
−Removed: versus trying to place and keep a mask on a traumatized patient.
+Added: The tongue depressor vacuum tube is inserted versus trying to place and keep a mask on a traumatized patient.
Management also believes the product can be self-administered.
−Removed: - Smart Patented Design - The product is designed specifically to immobilize the palate from reflex spasm and open the
−Removed: air passage using a replaceable tongue depressor vacuum tube.
−Removed: A controlled vacuum action (manual or CO2 powered), with specific
−Removed: negative pressure, has been carefully calculated enabling the lifting of a lodged mass from the throat, so it may be ejected by
−Removed: reflexive coughing.
−Removed: This device utilizes a negative pressure to gently uplift the object from the larynx, at which point it will
−Removed: be coughed upward and outward reflexively.
+Added: Smart Patented Design - The product is designed specifically to immobilize the palate from reflex spasm and open the air passage using a replaceable tongue depressor vacuum tube.
+Added: A controlled vacuum action (manual or CO2 powered), with specific negative pressure, has been carefully calculated enabling the lifting of a lodged mass from the throat, so it may be ejected by reflexive coughing.
+Added: This device utilizes a negative pressure to gently uplift the object from the larynx, at which point it will be coughed upward and outward reflexively.
Used on Anyone –
−Removed: The SAL can be used on infants (20 months plus) to elderly adults.
−Removed: Also, it can be use on pregnant
−Removed: women and others who the Heimlich maneuver cannot help.
−Removed: About Orphan Drugs for Niemann Picks
−Removed: and Amyotrophic Lateral Sclerosis (“ALS”)
−Removed: On June 27, 2019, Odyssey entered into a
−Removed: Definitive Agreement with Prevacus, Inc.
−Removed: (“Prevacus”), a biotechnology company, to form a Joint Venture (“JV”)
−Removed: relating to the development of a neurosteroid for treating two orphan disorders, Amyotrophic Lateral Sclerosis (“ALS”)
−Removed: and Niemann Picks disease.
−Removed: Prevacus will contribute to the JV, the chemical compound and Odyssey will be responsible for funding
−Removed: the JV through Phase One clinical trials.
−Removed: The JV company will own the patents.
−Removed: Each party will own the JV company equally.
−Removed: to the JV, the two companies have entered into a share exchange agreement whereby Prevacus will receive three million shares of
−Removed: Odyssey common stock and Odyssey will receive one million shares of Prevacus stock.
−Removed: The chemical compound for the neurosteroid
−Removed: being developed has issued patents, and as consideration for the patented compound, Odyssey will issue Prevacus two million shares
−Removed: of its common stock.
−Removed: Prevacus, a leading biotech company in
−Removed: the area of neurological disorders and brain trauma has a neurosteroid compound intended to treat rare brain disorders, such
−Removed: as ALS, Niemann Pick’s disease, Krabbe’s Disease, Metachromatic Leukodystrophy and other leukodystrophies.
−Removed: rare diseases are considered to have orphan drug status by the FDA.
−Removed: Orphan drug status is granted by the FDA and is
−Removed: intended to give companies that are researching cures for rare diseases that affect a small percentage of the population, a
−Removed: seven-year exclusive right to develop a cure and favorable tax considerations.
−Removed: The FDA Office of Orphan Products
−Removed: Development determines if a drug qualifies as an orphan product and drug status can be granted for new drugs,
−Removed: already approved drugs, or drugs that are already on the market.
−Removed: The Prevacus and Odyssey joint venture will
−Removed: seek a solution to improve function and lifespan in pediatric disorders where de-myelination and cell death is widespread in the
−Removed: cortex and cerebellum regions of the brain.
+Added: The SAL is designed to be used on infants (20 months plus) to elderly adults.
+Added: Also, it can be use on pregnant women and others who the Heimlich maneuver cannot help.
+Added: About the neurosteroid PRV-001
+Added: The Prevacus neurosteroid,
+Added: PRV-001 will seek to improve function and lifespan in pediatric disorders where de-myelination and cell death is widespread in
+Added: the cortex and cerebellum regions of the brain.
The new chemical entity is designed to work through gene amplification to simultaneously
remove intra-neuronal debris while promoting antioxidant capacity and myelin repair/cell proliferation.
−Removed: Disorders like Niemann
−Removed: Pick Type C disease are multi-faceted in their pathology and require a treatment that can work at many levels to stop progression.
−Removed: The chemical compound for the neurosteroid being developed has issued patents.
−Removed: Toxicology studies have been performed and show
−Removed: a 380-fold safety margin.
−Removed: Preclinical efficacy studies show improvements in cognitive function and neuromotor performance.
−Removed: We believe that the primary competition
−Removed: for our services is from existing companies offering EKG equipment and anti-choking devices, as well as other pharmaceutical companies
−Removed: engaged in the development of Orphan drugs.
+Added: Disorders like Nieman Pick
+Added: Type C disease are multi-faceted in their pathology and require a treatment that can work at many levels to stop progression.
+Added: chemical compound for the neurosteroid being developed has completed initial safety tests in mice.
+Added: Toxicology studies have been
+Added: performed and show a 380-fold safety margin.
+Added: Preclinical efficacy studies show improvements in cognitive function and neuromotor
+Added: In order to sell the PRV-001 neurosteroid, further development and clinical studies are required.
+Added: PRV-001 will also
+Added: require approval by the FDA in order to be sold in the United States.
+Added: Product Development
+Added: Pre-clinical Animal Studies
+Added: FDA Submission
+Added: Safety study complete
+Added: The product development
+Added: plan is an estimate only and is subject to change based on funding, technical risks and regulatory approvals.
+Added: We believe that the
+Added: primary competition for our products and services is from existing companies offering EKG equipment and anti-choking devices, as
+Added: well as other pharmaceutical companies engaged in the development of Orphan drugs.
Governmental Regulation
Product Regulation
−Removed: The processing, formulation,
−Removed: safety, manufacturing, packaging, labeling, advertising and distribution of our products may be subject to certain regulation by
−Removed: one or more federal agencies, including the FDA, Housing and Human Services (the “HHS”), the Federal Trade Commission
−Removed: (the “FTC”), the Consumer Product Safety Commission (the “CPSC”), the United States Department of Agriculture
−Removed: (the “USDA”) and the Environmental Protection Agency (the “EPA”), and by various agencies of the states
−Removed: and localities in which our products are sold.
−Removed: In order to sell, market and distribute
−Removed: the CardioMap®, the Save a Life or the drug compound products, clearance or approval from the FDA is required.
−Removed: Such clearance
−Removed: or approval has not been obtained at this time and our products are not currently available for commercial sale.
−Removed: Any products we eventually
−Removed: sell in foreign countries are also subject to regulation under various national, local and international laws that include provisions
−Removed: governing, among other things, the formulation, manufacturing, packaging, labeling, advertising and distribution of drugs and medical
−Removed: Government regulations in foreign countries may prevent or delay the introduction, or require the reformulation, of some
−Removed: of our products.
−Removed: At the date hereof, we have three employees
−Removed: (one full-time and two part-time) and intend to hire additional employees in the foreseeable future.
+Added: processing, formulation, safety, manufacturing, packaging, labeling, advertising and distribution of our products may be subject
+Added: to certain regulation by one or more federal agencies, including the FDA, Housing and Human Services (the “HHS”), the
+Added: Federal Trade Commission (the “FTC”), the Consumer Product Safety Commission (the “CPSC”), the United States
+Added: Department of Agriculture (the “USDA”) and the Environmental Protection Agency (the “EPA”), and by various
+Added: agencies of the states and localities in which our products are sold.
+Added: In order to sell, market
+Added: and distribute the CardioMap®, the Save a Life or the drug compound products, clearance or approval from the FDA is required.
+Added: Such clearance or approval has not been obtained at this time and our products are not currently available for commercial sale.
+Added: products we eventually sell in foreign countries are also subject to regulation under various national, local and international
+Added: laws that include provisions governing, among other things, the formulation, manufacturing, packaging, labeling, advertising and
+Added: distribution of drugs and medical products.
+Added: Government regulations in foreign countries may prevent or delay the introduction,
+Added: or require the reformulation, of some of our products.
+Added: At the date hereof,
+Added: we have three employees (one full-time and two part-time) and intend to hire additional employees in the foreseeable future.
+Added: Where you can find more information
+Added: The Company’s
+Added: Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, and amendments to reports filed pursuant
+Added: to Sections 13(a) and 15(d) of the Securities Exchange Act of 1934, as amended (“Exchange Act”), are filed with the
+Added: Securities and Exchange Commission (the “SEC”).
+Added: Such reports and other information filed by the Company with
+Added: the SEC are available free of charge on the Company’s website at http://www.odysseygi.com when such reports are
+Added: available on the SEC website.
+Added: The public may read and copy any materials filed by the Company with the SEC at the SEC’s Public
+Added: Reference Room at 100 F Street, NE, Room 1580, Washington, DC 20549.
+Added: The public may obtain information on the operation of the
+Added: Public Reference Room by calling the SEC at 1-800-SEC-0330.
+Added: The SEC maintains an Internet site that contains reports, proxy and
+Added: information statements and other information regarding issuers that file electronically with the SEC at www.sec.gov.
+Added: of these websites are not incorporated into this filing.
+Added: Further, the Company’s references to the URLs for these websites
+Added: are intended to be inactive textual references only.
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.