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Monday, July 06, 2020 9:12:10 PM
Have they submitted application to FDA or not yet?
Submitting an Application to be granted an FDA Emergency Use Authorization (EUA) is a meaningless exercise, when the test protocol does not work! CEO Keith Berman claims the EUA Application has been submitted, but he constantly uses the Pre-EUA Application to imply things about the actual EUA. With Berman nobody has the foggiest idea what's going on!
DECN has received and made public the Pre-EUA Application Acknowledgement Letters, but Berman has never made anything related to an actual EUA public! FYI, Berman claimed the FINAL testing to be granted an "Emergency Waiver" was to begin in late March! Now we are in early July and still no test data! Go figure!
BTW, DECN is responsible to do its own testing, then submit the certified results to the FDA. The FDA is holding up nothing! All the responsibility for no EUA belongs to CEO Keith Berman and a COVID-19 test kit that will NEVER meet the FDA's efficacy standards!
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