Item 8.01 Other Events
The Company has been following the recommendations of local health authorities to minimize exposure risk for its team members (officers and consultants) for the past several weeks, including the temporary closures of certain offices of its team members to work remotely, and, as a result, the quarterly report will not be completed by the filing deadline, due to insufficient time to facilitate the internal and external review process.
ACCORDINGLY,
In light of the current COVID-19 pandemic, the Company will be including the following Risk Factor in its Report:
Impacts of COVID-19 to Business and the general economy
Covid -19 has recently caused a material and substantial adverse impact on our general economy. It has also caused there to be a hold on our FDA application for class III approval of our hemostyp product for internal surgical purposes while the FDA deals with the Covid-19 crisis. Recently, this hold was lifted by the FDA. The impacts of the global emergence of Coronavirus disease (COVID-19) on our business and the general economy, are currently not fully known. We are conducting business as usual with some modifications to, employee work locations, among other modifications We have observed other companies taking precautionary and preemptive actions to address COVID-19 and companies may take further actions that alter their normal business operations. We will continue to actively monitor the situation and may take further actions that alter our business operations as may be required by federal, state or local authorities or that we determine are in the best interests of our employees, potential partners, suppliers and stockholders. It is not clear what the potential effects any such alterations or modifications may have on our business, including the effects on our prospects, although we do anticipate it to negatively impact our financial results and the length of time needed to obtain FDA approval of our hemostyp product for internal surgical purposes during fiscal year 2020.
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