Replies to post #90782 on Decision Diagnostics Corp (DECN)

[rawman]

CE MARK IS IMMINENT.

Not a chance! Getting regulator medical device authorization from the EU is just as difficult as securing an FDA authorization for the U.S.! If a product, like the GenViro! Swift Kit, doesn't meet the efficacy standards as mandated by the EU, it will NOT be granted the CE Mark!

[goodthings]

DECN shareholders, do you know what this quote means??

Quarterly Report : On April 1, 2020 the company planned to begin development work on its second product design, but 3rd Covid-19 test kit, a confirmation test for Covid-19.

This test, a hybrid but direct antibody/antigen (IgG) method, again making use of the company’s expertise in biosensors, was to be designed to be used on those the tested Positive Covid-19, and those that tested Negative
but are suspected to be false Negatives.

This product design is not yet in the advanced development cycle and the company (i.e. DECN) may shelve this product because the FDA has recently clamped down on applications for direct antibody/antigen methods due to a perceived lack of accuracy.

Can you paraphrase the above quote? I will go first. Correct me if I am wrong.

1. CEO Berman has been deceiving you and finally he confessed that DECN's technology for COVID-19 is crappy. The impostor has published many fraudulent PRs in order to raise the stock price, dragging his feet for more than 5 months. -- (Reread PRs.)

2. "DECN's serology test kits are suspected to be false Negatives."

"DECN may shelve this product because the FDA has recently clamped down on applications for direct antibody/antigen methods due to a perceived lack of accuracy."

--- A false negative is an error where a test result incorrectly indicates that a person is NOT infected with COVID-19 when he/she is actually infected with it.

In other words, DECN test kits cannot detect infected samples, so this company's tests have false negatives ( i.e. low sensitivity).

--- Berman does know DECN tests fall far short of the FDA standard, 90% sensitivity;
No EUA, No CE mark

Quarterly Report : The company plans to file a third EUA application for its GenViro! saliva based method, but this time will hold off on the application until the testing trials are complete and file the application along with the data ( i.e. testing results of sensitivity & specificity).

--- 1. First of all, DECN must file a Pre-EUA, but not an EUA Application.
FYI, the only thing that DECN received from the FDA is the Pre-EUA designation for its Serology test kits.

2. Berman mentioned that DECN serology tests and its saliva test are interchangeable. That is, the same DECN technology for both blood samples and saliva samples.

3. FDA has issued five EUAs for COVID-19 saliva tests so far, all of which demonstrated very high sensitivity.

FDA issued an EUA to Yale's SalivaDirect on August 15

Bloomberg on Aug.16 : The FDA says that Yale's test is accurate enough to meet the criteria for EUA.

1. Yale university submitted an EUA application, and it was accepted.
2. Yale submitted the FDA-mandated testing data along with its EUA request.
3. FDA sent an ACKNOWLEDGEMENT LETTER to Yale.
4. FDA determined the Yale's test, SalivaDirect meets the FDA criteria for an EUA.

--- FDA has issued five EUAs for COVID-19 saliva tests so far, all of which demonstrated very high sensitivity.

What about DECN's saliva test kit???

DECN PR on August 10 : The FDA should reduce burdensome sensitivity requirements.

Questions :
1. Does DECN has the "high technology" for its saliva test kit?? -- If yes, since when?

2. The partner in Korea is still trying to find a research institute or hospital to conduct clinical trials of infected samples???

--- The report says that Berman is talking with a U.S. lab for clinical trials.

Most importantly, if DECN/Berman does NOT announce of the sensitivity percentage of its saliva test kit in a news release, then that is the most obvious sign that DECN/
Berman is a SCAM: No EUA, No CE mark. --- Some have told you that DECN is a scam, but you don't listen to them.

Why only the saliva test???
Because Berman did confess that DECN's Serology test kits have false Negatives (i.e. poor sensitivity) in the Quarterly Report and the April 10th PR.

Raffis said : GenViro Saliva is FDA regulation exempt ; can sell immediately.

--- A CE mark is imminent???

I hope DECN shareholders make money, but stop lying for you to make money.