Decision Diagnostics Corp (DECN)

[cvinvestor]

Very quiet on the board for a day with a PR. Berman claims they will have testing data tomorrow. Will he release it?

Afterwards, the confusion continues as he seems to contradict himself, both saying that EUA will be filed within 3 weeks and later stating that only Russian CE Mark submission is on track for 4th Qtr submittal.

"Testing for GenViro! has been so encouraging that on Tuesday, November 10, 2020 our certified testing lab partner informed us that we can avoid doing two studies and instead move to direct patient testing of positive and negative Covid-19 human samples required for FDA submission. That's taking place right now" said CEO Keith Berman. "As such, we have been informed that testing is in the "home stretch," and we estimate an FDA submission estimated to be filed in the next 3 weeks or as soon as the complex EUA application is completed."

This statement further on indicates that FDA EUA and European CE Mark are not on track for 4th Qtr. So which statement is true?

DECN had previously targeted the fourth quarter, 2020 for FDA EUA, EU CE Mark and Russian Federation submissions. We do not anticipate any deviation from this schedule, at least as far as the application from the Russian Federation is concerned.

Then, after stating they are in final home stretch, he talks about using the testing to change the meter algorithms. What??? If you change the meter, you will have to retest. The FDA is not going to approve something if you change the reading meter after doing the testing. So, while seemingly very encouraging, this PR is far from clear as to where things really are in testing or final product develpment, as usual.

Berman further stated, "The current testing will also allow us to do the final programming of algorithms for the GenViro! Swift Kit meters, fixing the version level at version 1.7. We will also be enhancing our meters with the ability to provide a qualitative measure of certain probabilities. This additional meter feature, version 2.1, is expected to be implemented early in 2021.