Item 8.01 Other Events.
Response to SEC Release No. 88620 - Temporary Trading Suspension SOLI
The foregoing is a summary of the Notice and is qualified in its entirety by the Notice attached hereto and incorporated herein as Exhibit 99.1.
The Company, after careful review, understand how the
The Company is in the process of providing supporting documentation to the
Through our wholly owned subsidiary,
As discussed in the Press Release, the Company made our telemedicine services available to provide clinical screening to patients who were symptomatic, high priority, or high risk for the COVID-19 virus. We also made available to our providers a list of laboratories and testing facilities where patients can go to get testing, and this included an FDA approved test that those laboratories could ship directly to home.
The Company initially chose to work with a lab that used an FDA approved SARS-COV-2 Coronavirus test that met the FDA Emergency Use Authorization criteria. That lab is Next Molecular Analytics, a 23-year-old laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA). We relied upon the following communication from Next:
"We are pleased to announce NEXT is launching an FDA approved SARS-CoV-2
Coronavirus test for COVID-19 detection. This test meets the FDA Emergency Use
Authorization (EUA) criteria as it consists of the
Also,
In the
Concerning the screening process:
When a patient contacts CareClix:
· The patient enters patient information into patient portal
· Patient enters waiting room through browser, app or phone
· Patient receives consult by a CareClix doctor.
Every patient that comes to our medical group is assessed through history and clinical evaluation of their symptoms, past medical history, past surgical history, medication history, allergies, as well as any other relevant information before an assessment is determined
· The doctor makes a clinical assessment and care plan which may include
laboratory and or pharmacy as needed for the patient.
· Based on the patient's preference, the doctor offers either the ability to get
FDA approved home testing or directs the patient to a local testing sites. 1
Telemedicine has been performed in this same fashion since its inception for numerous medical conditions including its current usage for Covid19. This exact same process is being used for other conditions including but not limited to upper respiratory infections, urinary tract infections, pharyngitis, etc. Therefore, the above detailed process for managing Covid19 is the exact same process that every telehealth provider in the world is using to deliver medical services and offer laboratory testing for their respective patients.
For the foregoing reasons, the Company believes that all statements made in the
Press Release and the Interview are fully supported and were correct. We hope
that the
Item 9.01 Financial Statements and Exhibits. (d) Exhibits
99.1 SEC Notice of Temporary Trading Suspension dated
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