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Hopefull17

08/19/20 2:32 PM

#90888 RE: Johnny_C #90880

When can we expect the DECN EUA process to be complete?

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goodthings

08/19/20 2:36 PM

#90889 RE: Johnny_C #90880

plutoniumimplosion never answers my question, either.

plutoniumimplosion still thinks that FDA did accept the DECN's Applications for an EUA,
never giving me any proof .

FDA did not even accept the DECN's Applications for an EUA. --- I already provided the proof in my posts.

(August 14 Quarterly Report) : For FDA EUA filing and the granting of a Pre-EUA by the FDA, the company first filed an application for its Professional use version of its GenViro! Covid-19 test kit on April 3. We received PEUA ( i.e. PRE-EUA) designation from the FDA on April 4. Conversations with FDA review staff began in earnest on April 14. This application was for the point of care testing of blood from human subjects.

The company then filed a second EUA application with the FDA on May 1.
This application was for our individual use GenViro! test kits. We received PEUA (i.e. PRE-EUA) designation from the FDA on May 2.



By "This application" Berman meant the PRE-Eua Application.


--- plutoniumimplosion still thinks there is NO PRE-EUA application.


--- plutoniumimplosion, before you ask me the samerepeated question to me,
PROVE that the FDA accepted this company's Applications for an EUA.