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Posted On: 07/22/2020 11:34:35 AM
Post# of 11803
From DECN Consulting / Advisory firm sworn affidavit to the SEC:
"While a determination of the efficacy of Decision Diagnostics’s proposed COVID19 test kits must await completion of validation testing, it is my opinion that the evidence provided to me appears to demonstrate that the proposed test kits and their impedance technology provide a (so far) unique, researched, and legitimate basis for rapid and highly accurate test results to detect the presence of the Novel Coronavirus. The evidence provided to me on the GenViro! devices appears to demonstrate that the devices present an important advantage to assist in testing for the Coronavirus by providing an easy-to-use methodology that offers very fast results. If the validation testing of the GenViro! test, when completed, supports the FDA expectations for sensitivity and specificity for test kits designed to detect the Coronavirus, this device should be a very important
technology in the arsenal of diagnostics needed to address the current COVID-19 pandemic."
Here is the link to the document:
https://www.sec.gov/litigation/apdocuments/3-...-brief.pdf
About Lisa Prichard: http://www.duvalfdalaw.com/about-us/our-team/lisa-pritchard
Lisa L. Pritchard, being duly sworn, states:
1. I am a regulatory, quality, and compliance consultant with the regulatory law firm of DuVal & Associates, P.A. in Minneapolis, Minnesota. For over thirty years, I have specialized in regulatory, quality, and compliance topics with the Food and Drug Administration.
"While a determination of the efficacy of Decision Diagnostics’s proposed COVID19 test kits must await completion of validation testing, it is my opinion that the evidence provided to me appears to demonstrate that the proposed test kits and their impedance technology provide a (so far) unique, researched, and legitimate basis for rapid and highly accurate test results to detect the presence of the Novel Coronavirus. The evidence provided to me on the GenViro! devices appears to demonstrate that the devices present an important advantage to assist in testing for the Coronavirus by providing an easy-to-use methodology that offers very fast results. If the validation testing of the GenViro! test, when completed, supports the FDA expectations for sensitivity and specificity for test kits designed to detect the Coronavirus, this device should be a very important
technology in the arsenal of diagnostics needed to address the current COVID-19 pandemic."
Here is the link to the document:
https://www.sec.gov/litigation/apdocuments/3-...-brief.pdf
About Lisa Prichard: http://www.duvalfdalaw.com/about-us/our-team/lisa-pritchard
Lisa L. Pritchard, being duly sworn, states:
1. I am a regulatory, quality, and compliance consultant with the regulatory law firm of DuVal & Associates, P.A. in Minneapolis, Minnesota. For over thirty years, I have specialized in regulatory, quality, and compliance topics with the Food and Drug Administration.
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