Replies to post #83646 on Decision Diagnostics Corp (DECN)

[IPwatcher]

If they get EUA and then don't provide 100,000 kits, complain, but until then complain to the FDA if you want.

On the contrary, if DECN have as yet failed to submit an EUA application which meets the evidence standard required by the FDA, that is not the fault of the FDA!. Others have managed!
It means that either the test is not up to the job as was claimed, or else the evidence required to confirm this to an acceptable standard has not been submitted to the FDA by DECN in a timely fashion.
In either case, that is the fault and responsibility of DECN ,not the fault or responsibility of the FDA.

The FDA has had no difficulty in issuing timely clearances for competitive Covid 19 test systems from companies large and small, with alacrity. Indeed many here have been critical of the haste with which tests have been authorized.

My own view is that the FDA will NEVER clear this system. Because it simply cannot work for the purpose to which it was intended. It would, in fact be dangerous! by dint of false negative rates of at least 80% and more likely 99%.
And I have presented compelling evidence in support of that honestly held view.

DECN might - in theory - eventually - get some sort of approval on an antibody based blood test, but they are a very very long way behind the herd on even this, and it would certainly not be remotely ground breaking.
And this is not what they claimed Genswift is hitherto.

It doesn't look good!