William H. Dailey, Esq.
Attorney at Law
16161 Ventura Blvd #748
Encino, CA 91436
310 308 8717
310 861 8840 fax
william@attorneydailey.com

March 24, 2020
George A. Todt
Director, Business Affairs
Wellness Matrix Group, Inc.
Via Email
RE:

The Coronacide Test
Emergency Changes to FDA mandatory approval procedures
Effect of FDA's Policy for Diagnostic Tests ... and Guidance issued March 16, 2020.

Dear Mr. Todt and whomever else this concerns:
As per request, this office has reviewed the FDA's most recent emergency changes to the currently published
regulatory requirements for such products and the materials provided by the company executives, personnel and
outside consultants. Based on the review of said materials, please accept our opinion on the current regulatory status
of the Coronacide test.
By reason of its presence on the FDA's list of products approved pursuant to Section IV (D) of the March 16,
2020 issued Policy and Guidance document, the Coronacide test may be legally marketed and sold in the US for
Point of Care (POC) testing. This approval is only for the test to be marketed and sold pursuant to the requirements
listed below, and without further regulatory process beyond placement on the Section IV(D) list.
Point of Care (POC) Defined: POC tests are designed to be used at or near the patient's location, said location
intended to be at a dedicated medical office or clinic without requiring testing at the physical facilities of the clinical
laboratories. In other words, a test performed outside of a lab at a location where the patient is receive medical care
as necessary.
At this time the FDA's stated position is that POC use takes place at a medical office or clinic so that an MD
can review the test results and immediately take medically appropriate actions. Coronacide's test fits within the
FDA's stated POC definition.
FDA Required Compliance:The March 16, 2020 issued Policy and Guidance document mandates that a listed
product meet three specific qualifications.
First, that the test has been validated with respect to Cross-reactivity/Analytical Specificity, Class Specificity,
and Clinical Agreement with positive human specimens to determine sensitivity/PPA and specificity/NPA. This part
has already been achieved.
Second, that the test is only provided for use by clinical laboratories or to healthcare workers for point-of-care

 testing, and not for at home testing. Also not a problem.
Third, that the test includes instructions that the test reports include information along the following lines:
1. This test has not been reviewed by the FDA.
2. Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with
the virus. Follow-up testing with a molecular diagnostic should be considered to rule out infection in these
individuals.
3. Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2
infection or to inform infection status.
4. Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as
coronavirus HKU1, NL63, OC43, or 229E.
5. And the test may not be sold or used for the screening of donated blood.
The Coronacide test's product can easily provide the required information.
Given the nature of this crisis, total transparency should govern all company communications with the
consumers and the government.

Every product ingredient and efficacy claim must be adequately supported by

properly structured scientific research and testing, and scrupulously honestly represented to the consumer.
company must inform all consumers of the required information listed above.

The

Compliance with standard

regulatory approval procedures is only temporarily waived. After the crisis is abated all products will be required to
retrospectively comply with FDA's regulatory approval process.
Conclusion:

Meanwhile, subject to compliance with the conditions stated above, the Coronacide test may be

marketed and sold for use as a POC test. Every hospital, clinic and medical office in the country is a possible
customer.

Any other corporate or bulk purchaser who intends to use the tests in compliance with the POC

requirement is also a possible consumer.
If you have any questions, please feel free to call, text or email me.
Sincerely,
William H. Dailey, Esq.