Decision Diagnostics Corp (DECN)

[cvinvestor]

For any sustained trading, DECN will need to release actual, verified test results data.

The PR muddles things because it talks about better than expected testing, but also mentions that testing will allow them to alter the meter algorithms, which means they will need more testing to have validated results with the final product to be presented to FDA for EUA, unless the initial testing is above EUA standards and they submit an initial application on the current meter and then adjust to improve the meter later for a modified submission, but given all other factors, that wouldn't seem to make much sense.

What is revealing, is that Berman mentions finalizing the meter temporarily at 1.7, which seems to indicate they have changed the meter (adjusted settings/algorithms) 7 times over the course of the development since March all the while saying that they had a test that worked and had been tested. But it seems the testing showed that the kit needed consistent adjustments/improvements over that time in order to be able to meet FDA standards.

Is the rocky road coming to a positive conclusion. Hard to say, but given that several other saliva kits are out there, DECN has a decent chance on the Saliva kit, but I wouldn't bet on the blood kit ever being approved.

Good news is that they only need one to work.