Decision Diagnostics Corp (DECN)

[rawman]

Once and if they pass the FDA data testing guidelines given after the PRE-EUA approval letter, they would be able to manufacture, sell and distribute immediately.

Being "ALLOWED" to manufacture and distribute is very different than "HAVING THE CAPACITY TO MANUFACTURE" and distribute.

DECN will NOT have it's early manufacturing scale-up completed until AUGUST 2020!

BTW...the mentioned 250,000 kits to be split between the U.S., Canada, and Europe will be pre-production bench-assembled units. And, BTW, since the finalized product specification will not be completed until mid-May, 250,000 bench-assembled units in the month of May would seem to be a bit of a fantasy, not reality!

All of the above was discussed and confirmed in DECN's Supplement Information Statement, which was signed and attested by CEO Keith Berman on March 30, 2020!

WANT FACTS? The 70-page CEO-signed document would be a good place to start!

The following two quotes were copied directly from DECN's Supplemental Information Statement, which was posted to OTC Markets on March 30, 2020.

(FYI, an FDA PRE-EUA is NOT SOME SORT OF MAGIC WAND that can instantly finalize a product specification and/or construct a manufacturing facility!)

As of this writing, work has commenced on the product specification...with components such as the platinum electrodes, platinum carbon paste, industrial films (several types) to make the biosensor, and perhaps a new impedance chip for the meter. The company is operating on an 8-week development schedule and is some 10 days into this schedule. The current development cycle is considered advanced development. For FDA EUA filing and the granting of a Pre-EUA by the FDA, the company is preparing its final working concept filing, to be completed within days of this writing.

(Please make note the "effect" of the anticipated FDA actions are noted in the document. Nothing has changed in terms of the FDA's impact on the product design, manufacturing scale-up, and/or product availability.)

In the next 120 days the company expects to enter the Covid-19 test kit market with unique, cost effective, accurate and wholly proprietary products.

https://www.otcmarkets.com/stock/DECN/disclosure