Decision Diagnostics Corp (DECN)

[cvinvestor]

How come the testing of kit was not done before suspension? Seems like that would have been a good use of company time..

but no test results..

Company has stated in a PR that kits were tested in South Korea where they have conducted all their clinical trials. As others have posted, to get a review process from the FDA on your application, you have to provide enough data for them to believe it can work.

The FDA review process is not just on your data; you have to establish exactly what they (FDA) want/need in order to give final approval. Sometimes, this can take a long time to establish, but it appears the FDA is working very quickly for COVID-19 related issues and the company, in its press releases has stated when it thought it had all the guidelines from the FDA necessary to move forward with the required testing, which DECN described as "rigorous".

Specialty labs, with all the approvals and testing guidelines in place are not on every street corner, so you have to find one that is not backed up, understands the testing and guidelines controlling the testing and is available to move forward with the testing.

It is our understanding both from the company's PRs and the CBS news report, that hopefully that testing in the USA according to FDA guidelines will be completed very soon.

That will be the key to what happens next.