Decision Diagnostics Corp (DECN)

[cvinvestor]

Insights from yesterday's PR:

"While we continue to wait for the FDA to APPROVE last issue in our testing protocol, even as we have begun the testing

today's testing sources simply do not meet the requirements that are necessary for employees to keep themselves safe while also allowing employers safely to keep their businesses up and running or, in many situations, to resume operations with procedures in place that will entice employees to return to work. Immediate and accurate test results must be available.

PharmaTech Solutions "Swift Kit" testing kit is designed to provide the answers individuals and employers need. It is engineered to provide accurate results on the spot with no delay. While the FDA continues its assessment of how to move forward with this technology,

Bold emphasis is mine. What has KB communicated to us via the PR yesterday: that DECN is waiting on the FDA and not the other way around. The expansion of the timeframe from the prior PR, (10 days to find a lab and 7 days to complete testing, pointing to completion of testing by now, has been changed because the FDA is changing the rules as it goes along or having to create new ones.

So, remember this when others claim its a scam because we don't have news of testing yet. We know the FDA seems to be regretting allowing so many anti-body tests to proliferate as many are not accurate. (KB refers to this in PR as well.)

KB states via yesterday's PR that since DECN's tests are not anti-body tests, the FDA doesn't seem to have a written rule book to clearly state what is needed for DECN's tests to pass approval. DECN has begun the Specialty Lab testing it seems, but is waiting on the FDA to determine a final aspect of the testing protocol. This is why KB mentioned in other recently filed documents that they were 36 days into an 8 week development cycle and the final 2-3 weeks will be used for testing. At first this bothered me as a significant change in the testing time frame, but yesterday's PR clears the reason as to why. And it's not DECN sitting on laurels or not having enough test kits. It is the fact that they are waiting on finalized FDA protocols to get their product testing exactly how the FDA needs it so as to avoid any need for further testing after submitting the data.

That's why he also mentions "While the FDA continues its assessment of how to move forward with this technology"... DECN's test is unique and something new. Hopefully the SEC is starting to understand that as well and there can be a good resolution to the 550 Petition.

But we may have to wait a few extra days for the testing results, hopefully that is an honest FDA issue and not pressure from the bigger testing companies' influence over any FDA personnel.