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Therefore, it is possible the outcome of such legal proceedings, claims and litigation could have a material effect on quarterly or annual operating results or cash flows when resolved in a future period.
−Removed: There were no legal proceedings pending as of August 31, 2020.
+Added: There were no legal proceedings pending as of November 30, 2020.
As disclosed in the Form 10K filed with the SEC on August 31, 2020, on July 2, 2020, the Company received a notice of investigation and subpoena to produce information and documents from the Division of Enforcement of the SEC.
−Removed: The subpoena seeks information and documents related to events and circumstances leading up to our March 17, 2020 announcement that we had commenced shipping samples of our COVID-19 IgG/IgM Rapid Test to countries outside of the United States, and had initiated the application process with the United States Food and Drug Administration under the COVID-19 Emergency Use Authorization for approval to market and sell the test in the United States.
+Added: The subpoena seeks information and documents related to events and circumstances leading up to the March 17, 2020 announcement that the Company had commenced shipping samples of the Companys COVID-19 IgG/IgM Rapid Test to countries outside of the United States, and had initiated the application process with the United States Food and Drug Administration under the COVID-19 Emergency Use Authorization for approval to market and sell the test in the United States.
The subpoena also seeks information and documents about the identity of any persons who were aware of the substance of the March 17, 2020 announcement prior to that date.
−Removed: The Company is continuing to cooperate fully with the SECs investigation and provide information as requested.
−Removed: At this time, the Company is unable to predict the duration, scope or outcome of this investigation.
+Added: In addition, on December 15, 2020, the SEC sent a second subpoena related to this investigation to Zack Irani, the Companys CEO, requesting documents held by Mr.
+Added: Irani concerning his past purchases of Company stock, any past communications with certain persons and entities, and other personal and Company documents.
+Added: The Company and Mr.
+Added: Irani are continuing to cooperate fully with the SECs investigation and provide information as requested.
+Added: At this time, the Company is unable to predict the duration, scope or outcome of these investigations.
RISKS AND UNCERTAINTIES .
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Our business could be adversely affected by the effects of widespread public health epidemics .
−Removed: We are susceptible to a widespread outbreak of an illness or other health issue, such as the recent COVID-19 Coronavirus outbreak first reported in Wuhan, Hubei Province, China in December 2019 and subsequently spreading throughout the world resulting in hundreds of thousands of confirmed cases worldwide and many deaths.
−Removed: The outbreak of the COVID-19 virus has caused the various governments, including the U.S., to implement quarantines, various restrictions on travel causing airlines to suspend international and certain domestic flights, shelter in place orders and other restrictions.
+Added: We are susceptible to a widespread outbreak of an illness or other health issue, such as the recent COVID-19 Coronavirus outbreak first reported in Wuhan, Hubei Province, China in December 2019 and subsequently spreading throughout the world resulting in tens of millions of confirmed cases worldwide and hundreds of thousands of deaths.
+Added: The outbreak of the COVID-19 virus has caused virtually all governments, including the U.S., to implement quarantines, various restrictions on travel causing airlines to suspend international and certain domestic flights, shelter in place orders and other restrictions.
Governments have also implemented work restrictions that prohibit many employees from going to work, and for businesses that are allowed to remain open, many employees are electing to remain at home to avoid spread of the disease.
+Added: In addition, infections among employees at Companys like ours is causing significant work disruptions.
As a result of this COVID-19 virus outbreak and potential future pandemic outbreaks, the Company faces significant risks including, but not limited to:
−Removed: a) supply chain disruptions making it difficult for the Company to contract and receive materials needed for production of its products, and needed to ship finished products to our end customers, b) loss of contracts and customers from the financial strains or other disruptions they are experiencing as a result of the pandemic, c) financial risks pertaining to receivables due from customers that may fall into insolvency or otherwise be unable to pay their bills, d) government responses including orders that make it difficult to remain open for business, restrict imports of raw materials or exports of finished goods, refusal to allow the Companys product to be licensed for sale in their countries, and other seen and unforeseen actions taken by government agencies, e) absenteeism or loss of employees at the Company, or at our partners companies, due to health reasons or government restrictions, that are needed to develop, validate, manufacture and perform other necessary functions for our operations, f) equipment failures, loss of utilities and other disruptions that could impact our operations or render them inoperable, g) litigation or government actions against the Company pertaining to existing products, new products sold by the Company that are directed at limiting or treating the spread of the pandemic outbreak, h) a local or global recession or depression that could harm the international banking system, limit demand for all products including those made by the Company, i) a drop in demand for our products, that are all medical related, due to patients reluctance or refusal to visit hospitals, labs, and doctors offices where our products are used due to their fear of contracting a disease, and many other seen and unforeseen events and circumstances, all of which could negatively impact the Company.
+Added: a) supply chain disruptions making it difficult for the Company to contract and receive materials needed for production of its products, and needed to ship finished products to our end customers, b) loss of contracts and customers from the financial strains or other disruptions they are experiencing as a result of the pandemic, c) financial risks pertaining to receivables due from customers that may fall into insolvency or otherwise be unable to pay their bills, d) government responses including orders that make it difficult to remain open for business, restrict imports of raw materials or exports of finished goods, refusal to allow the Companys product to be licensed for sale in their countries, and other foreseeable or unforeseen actions taken by government agencies, e) absenteeism or loss of employees at the Company, or at our partners companies due to COVID-19 infection or infection of employee family members or do to other health reasons, f) government restrictions, that are needed to develop, validate, manufacture and perform other necessary functions for our operations, g) equipment failures, loss of utilities and other disruptions that could impact our operations or render them inoperable, h) litigation or government actions against the Company pertaining to existing products or new products sold by the Company that are designed to detect if a person has been infected by the COVID-19 virus or designed to help limit the spread of the pandemic outbreak, i) a local or global recession or depression that could harm the international banking system, limit demand for all products including those made by the Company, j) a drop in demand for our products, that are all medical related, due to patients reluctance or refusal to visit hospitals, labs, and doctors offices where our products are used, due to their fear of contracting a disease, and many other seen and unforeseen events and circumstances, all of which could negatively impact the Company.
If our COVID-19 tests are unable to gain acceptance in the market, prove to be ineffective or less effective than expected, and/or we do not receive regulatory approvals for our COVID-19 tests to be sold, our results of operation could be materially harmed.
Although we believe that our COVID-19 tests represent promising tests to detect prior COVID-19 virus exposure, the tests may never gain significant acceptance in the marketplace and therefore may never generate substantial revenue or profits for us.
−Removed: We will need to establish a market for our COVID-19 antibody tests.
+Added: We will need to establish a market for our COVID-19 antibody and antigen tests.
Gaining acceptance in medical communities requires increasing awareness of our COVID-19 tests and their benefits.
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our ability to source required raw materials in a cost effective and timely manner;
+Added: manufacturing capabilities of our materials partners and their ability to meet our quality and delivery requirements;
mutations in the COVID-19 virus that render our tests ineffective;
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for approval;
−Removed: whether the medical community accepts our COVID-19 tests as a supplement to, alternative to, or complimentary to, current PCR or other tests for
−Removed: COVID-19 infection.
+Added: whether the medical community accepts our COVID-19 tests as a supplement to, alternative to, or complementary to, current PCR or other
+Added: tests for COVID-19 infection.
In addition, each country in which we wish to sell these tests has its own regulatory approval requirements.
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government for the export of goods to China or other countries;
+Added: tariffs or restrictions implemented by the Chinese government on shipments of raw materials to us from our suppliers in China;
any changes in our business relationships with international distributors or the economic climate they operate in;
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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.