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Re: pastrychf05 post# 74983

Thursday, 04/23/2020 1:20:18 PM

Thursday, April 23, 2020 1:20:18 PM

Post# of 97081

Do we even know if we are getting the EUA at this point, if they are just testing the kits now?

And why bother with a second kit application for the EUA, if we don’t even know that we are getting approval on the first one??



If USA specialty lab results validate the kit, don't sell under $10 in my opinion.

Where we are at and you can read my summary post #70571 of past PRs for faster catch up:

DECN filed EUA application for their "Swift" on site 15 second test for POC testing via official healthcare offices, first responders etc. because that is what FDA was approving for EUA.

They stated they would have filed for both kits in one application, but they decided that was too risky as no home kits for testing were being approved at the time.

All that appears to be between DECN and EUA approval is the passing of USA lab testing results which they stated today should happen within the next 10 days with testing itself taking 7 days.

Once that is done, if test results confirm the accuracy of the test kits, EUA should follow soon after.

You file the second test kit EUA before approval of the first to get it in the pipeline and they took the approval of a home collector test to be the sign that the timing was right to submit their own home test kit.

Hope that helps.