Replies to post #90879 on Decision Diagnostics Corp (DECN)

[Johnny_C]

When can we expect the EUA process to be complete

[goodthings]

(big sigh) plutoniumimplosion, you really don't understand even if others and I already explained to you.

Can anyone help me understand based on the Quarterly Report and the April 7th PR???

(plutoniumimplosion said) There are no Pre-EUA applications from the FDA. But here's last chance. Please post one if it is a (FACT). Proof, any proof.

April 7th News Release : "The company has received the Pre-EUA Acknowledgement letter from the U.S. FDA
for device (serial number) PEUA200232, GenViro Covid-19 Screening Kit."

--- Now read the following quote from the Quarterly Report saying
"The company first filed on application ~ on April 3 and received PEUA, but not just EUA."

According to the April 7th News, Berman said he filed an application and received the Pre-EUA designation &PEUA200232.

DECN's Quarterly Report submitted on August 14 :

(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. 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 a second EUA application Berman should have written "[color=red]Pre-Eua[/color]" like the April 7th PR ,
instead of just the "EUA application."

After April 7, Berman just keep saying "EUA" applications, but he should have stated
"Pre-EUA." --- The SEC file in July said the company is still in the Pre-EUA stage.


--- Remember that DECN received only PRE-EUA numbers
( i.e. PEUA200232 & PEUA200947), but not EUA submission number such as EUA2019 like Plexense, INC.



April 7th News Release saying PRE-EUA :

https://www.accesswire.com/584102/DECN-Receives-Pre-EUA-Acknowledgement-Letter-And-Product-Serial-Number-From-US-FDA-For-GenViroTM-Covid-19-Screening-Kit-For-Professional-Use