What changed in this filing

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Item 1A. Risk Factors

2020-12-11 compared with 2020-06-04 · 30 added, 112 removed, 0 unchanged (100% of the section changed)

In addition to the other information set forth in this report,

you should carefully consider the factors discussed in Part I, Item 1A, “Risk Factors”

in our Annual Report on Form

10-K for the year ended July 31, 2019, which factors could materially affect our business, financial condition, liquidity or future

There have been material changes to the risk factors described in the “Risk Factors”

section in our Annual

Report on Form 10-K for the year ended July 31, 2019, as so updated.

The risks described in our reports on Forms 10-K and 10-Q

are not the only risks facing our Company.

The following risks could materially affect the performance of the Company.

Risks Relating to our Business

Our success depends on the viability

of our business model, which is unproven and may be unfeasible.

Our revenue and income potential are unproven,

and the business model of Odyssey is new.

Our new business model is based on a variety of assumptions based on a growing trend

in the Health Care Systems in the United States and many other countries, where we are seeing a movement towards preventative medicine

that is directly decreasing general health care costs.

The CardioMap®, through its screening

and predictive values, is a tool that might be implemented in this preventative approach.

Considering heart disease-caused deaths

are still the number one cause of death and one of the most important health care costs factors, the CardioMap®

potential value in any medical practice.

The CardioMap®

will require a 510k clearance from the FDA.

Once FDA cleared, it could

be an ideal device allowing insurance companies to cut costs through early diagnostic and preventative care.

These assumptions

may not reflect the business and market conditions we actually face.

As a result, our operating results could differ materially

from those projected under our business model, and our business model may prove to be unprofitable.

The Save a Life®

choking rescue device

the device is un-proven for commercial use.

Further development is required, and the final product will require 510k clearance

from the FDA.

There is no assurance that the FDA will approve the device for commercial sale.

The drug compound being developed by Prevacus

was tested in animals.

The drug will require additional extensive testing and clinical trials before it is commercialized.

is no guarantee that the drug will be approved for commercial use.

Failure to implement our business

strategy could adversely affect our operations.

Our financial position, liquidity and results

of operations depend on our management’s ability to execute our business strategy.

Key factors involved in the execution

of the business strategy include:

obtaining the required regulatory clearances from the FDA;

successful sales through indirect sales distribution;

Transition successfully to a third part manufacturer;

continued investment in technology to support operating efficiency;

continued access to significant funding and liquidity sources;

Ability to manufacture the devices and drug once they are fully developed and approved by the FDA.

Our failure or inability to execute any

element of our business strategy could materially adversely affect our financial position, liquidity and results of operations.

We are subject to extensive government regulation and

must continue to comply with these regulations or our business could suffer.

Our products and manufacturing operations

are subject to extensive government regulation in both the U.S.

If we cannot comply with these regulations, we may

be unable to distribute our products, which could cause our business to suffer or fail.

In the U.S., the development, manufacture,

marketing and promotion of medical devices are regulated by the Food and Drug Administration (“FDA”) under the Federal

Food, Drug, and Cosmetic Act (“FFDCA”).

The FFDCA provides that new pre-market notifications under Section 510(k) of

the FFDCA are required to be filed when, among other things, there is a major change or modification in the intended use of a device

or a change or modification to a legally marketed device that could significantly affect its safety or effectiveness.

manufacturer is expected to make the initial determination as to whether the change to its device or its intended use is of a kind

that would necessitate the filing of a new 510(k) notification.

The FDA may not concur with our determination that our current

and future products can be qualified by means of a 510(k) submission or that a new 510(k) notification is not required for such

FDA regulatory processes are time consuming

and expensive.

Product applications submitted by us may not be cleared or approved by the FDA.

In addition, our products must be

manufactured in compliance with Good Manufacturing Practices, as specified in regulations under the FFDCA.

The FDA has broad discretion

in enforcing the FFDCA, and noncompliance with the FFDCA could result in a variety of regulatory actions ranging from product detentions,

device alerts or field corrections, to mandatory recalls, seizures, injunctive actions and civil or criminal penalties.

We will rely on third parties to manufacture our products .

The Company does not plan to manufacture

our products.

Manufacturing will be outsourced to third party manufacturers.

There is no assurance that these manufacturers will

be successful.

It is possible to have manufacturing defects or delays.

We have not yet formed the joint venture with our partner.

The Company entered into an agreement with

Prevacus to form a joint venture to commercialize neurosteroid, PRV-001.

The agreement to form the joint venture has been extended

to June 26, 2020.

There can be no assurances that the Company and Prevacus will finalize the terms and the joint venture agreement

will be cancelled.

The Covid-19 pandemic may have a negative impact on our

As the novel coronavirus pandemic continues

to severely impact the U.S.

and global economy, our business may be impacted in a variety of ways.

Political, legal or regulatory

actions as a result of the COVID-19 pandemic in jurisdictions where we may plan to manufacture, source or distribute products

have created supply disruptions which could affect our plans, and may cause additional supply disruptions or shortages in the

We cannot currently predict the frequency, duration or scope of these governmental actions and supply disruptions.

example, several countries, including India and China, have increased or instituted new restrictions on the export of medical

or pharmaceutical products that we distribute or use in our businesses, including key components or raw materials.

authorities in many countries, including the U.S., are enacting legislative or regulatory changes to address the impact of the

pandemic, which may restrict or require changes in our operations, increase our costs, or otherwise adversely affect our operations.

Recent Sales of Unregistered Securities

Issuer Purchases of Equity Securities

Default on Senior Securities

Not applicable.

Mine Safety Disclosures

Not applicable.

There have been no material changes during

the three-month period ended October 31, 2020 to the risk factors discussed in our Annual Report on Form 10-K for the year

ended July 31, 2020.

If any of the identified risks actually occur, our business, financial condition and results of operations

could suffer.

The trading price of our common stock could decline and you may lose all or part of your investment in our common

The risks and uncertainties described in our Annual Report on Form 10-K for the year ended July 31, 2020 are not the

only ones we face.

Additional risks that we currently do not know about or that we currently believe to be immaterial may also

impair our business operations.

The following exhibits are filed herewith and this list constitutes

the exhibit index.

Exhibit Number

Exhibit Description

Rule 13(a)-14(a)/15(d)-14(a) Certification of Chief Executive Officer and Chief Financial Officer

Section 1350 Certification of Chief Executive Officer and Chief Financial Officer

XBRL Instances Document

XBRL Taxonomy Extension Schema Document

XBRL Taxonomy Extension Calculation Linkbase Document

XBRL Taxonomy Extension Definition Linkbase Document

XBRL Taxonomy Extension Label Linkbase Document

XBRL Taxonomy Extension Presentation Linkbase Document

Pursuant to the requirements of Section 13 or 15(d) of

the Securities Exchange Act of 1934, the registrant has duly caused this Report to be signed on its behalf by the undersigned,

thereunto duly authorized, as of December 10, 2020.

ODYSSEY GROUP INTERNATIONAL, INC.

/s/ Joseph Michael Redmond

Joseph Michael Redmond

Chief Executive Officer, Chief Financial Officer, President and Director

(Principal Executive Officer and Principal Financial and Accounting Officer)

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.

What changed 10-Q

Item 1A. Risk Factors