Decision Diagnostics Corp (DECN)

[cvinvestor]

Here is full statement and context of March 3rd PR:

Keith Berman, CEO of DECN commented, "We have the technology perfected which will take months off of the development schedule. Our impedance powered diagnostic will be field tested at ground-zero in Daegu, Korea, where 700+ people have already been overcome by Coronavirus (COVID19) and where all of the clinical studies for our "Gen" products were tested. Our timing here is spot-on."

"Technology perfected" in the context of previous PRs and filings clearly refers to the development of their impedance platform and meter technology. In the context of the statement he is declaring that they have advanced and perfected (brought to a point of improvement where it works consistently and reliably where it doesn't need any further improvement to work, i.e. completed) the platform where "it will take months off of the development schedule". He is simply stating that they are not starting from scratch or with untested waters, they have advanced a technology to the point that they know what works, what doesn't and that platform technology in hand will speed up the new test development. If the SEC truly got riled up over the use of the word "perfect", they've got real problems.

The second quote from the April 23rd PR refers to the required FDA guidelines testing that needs to be done in the US under US regulations per FDA as FDA usually doesn't accept data testing done in a foreign country. Even if the test kits were in use already all over the world, testing would still be required in a US lab I believe. Does anyone really think KB would hire media, lobbyists, work on distribution and take out several million in loans to expand manufacturing for a product they never tested before filing an EUA? Come on people, let's think a bit.


And don't be expecting FDA approval before May 8th. We can hope that testing is done by May 8th and that the test results are positive, confirming the company's technology. That would be sufficient for me and all the reason anyone would need to hold/buy more. But the testing completion is not under the company's control, it is dependent on the specialty labs schedule, availability etc. and we know from prior PRs that the company stated that the FDA guidelines demanded "rigorous" testing, not the prick my finger on TV that some have suggested.

Timing of FDA's process is anyone's guess, but passing the FDA's US required testing should indicate at least EUA approval if not more.