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Friday, July 03, 2020 10:33:07 AM
EUA approval procedure:
1. Submission of data
2. Pre-EUA registration number issued by FDA
3. Additional documents requested by FDA within 2 weeks
4. Submission of FDA-mandated Testing results --- [DECN has never submitted them.]
5. Product listing on the FDA website & an EUA registration number.
--- Plexense Antibody test kit got an EUA registration number and is listed
on the FDA's homepage.
FYI, now, all the countries in the world including the States visit the FDA's website
in order not to purchase crappy tests like DECN test kits.
6. EUA review & EUA approval
Note: "Sales" are immediately allowed as soon as an EUA registration number is issued by FDA, and the test for COVID-19 is listed on the FDA website. -- That is, an EUA registration number is given in advance to the product eligible for an EUA.
However, DECN test kits only have a Pre-EUA number which all applicants received.
CEO Berman hasn't finished the first clinical testing for 4 months since March
(120 days)???
Why can't Berman tell you the exact sensitivity level for 120 days??
No EUA to DECN Test kits because of the stupid technology for COVID-19.
"Be wise, good-hearted, and beautiful."
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