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Friday, January 07, 2022 7:43:56 PM
First off, antibody test kits, and more importantly, Neutralizing antibody (Nabs) test kits, are, in a clear exaggeration, "a dime a dozen" (actually, they are much more expensive per test than Immunopass is/will be).
The link below directs you to the FDA's website, where you will see that the last dozen to a dozen and a half or so of the EUA approvals by the FDA have ALL been for antibody test kits of one type or another, and ALL of which require the results to be determined by laboratory technicians:
https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-serology-and-other-adaptive-immune-response-tests-sars-cov-2
BUT, look at this News Announcement by the FDA on November 15, 2021:
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-updates-test-policies-help-ensure-accuracy-and-reliability-tests-and
and AXIM's (unusual, unprecedented) response to that Announcement in a Press Release dated 3 days later:
https://www.globenewswire.com/news-release/2021/11/18/2337634/33692/en/AXIM-Biotechnologies-Applauds-FDA-s-Recent-COVID-19-Test-Policies-to-Support-Rapid-Neutralizing-Antibody-Tests.html
If you read both of the above carefully, it looks like the FDA is saying:
The FDA remains committed to helping to increase the availability of tests that will have the biggest impact on the nation’s ongoing COVID-19 testing needs, such as at-home and point-of-care diagnostic tests that can be produced in high volumes,”
The fact that AXIM took the unusual act of issuing a Press Release more than suggests that the FDA's announcement is in great support of Immunopass:
As part of the agency’s mission to support increased access to at-home and point-of-care COVID-19 testing efforts, the FDA has announced its focus on emergency use authorization (EUA) requests for various diagnostic tests for use with or without a prescription that can be manufactured in high volumes. This includes lab-based and point-of-care high-volume antibody tests that can measure the amount of antibodies (fully quantitative antibody tests) or the amount of neutralizing antibodies. This further supports AXIM’s development of its Rapid Neutralizing Antibody Test for COVID-19.
The Bold emphasis in the two quotes above are my own, but the quotes were directly extracted from the links that I provided.
There is more to Immunopass than what may at first meet the eye.
Please note that my posts are for discussion only. They should NOT BE CONSIDERED AS ADVICE FOR YOUR OWN PERSONAL INVESTMENT CHOICES. ALWAYS do your own DD and feel free to question or validate my posts at anytime.
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