At least it appears more and more likely that the ARYC submission to the FDA for approval is the finger stick allergy test.
If that is the case why is it taking more than a year for FDA approval?
If the FDA has requested additional data as you conjecture, Mark would have had to put out an 8K to notify shareholders of this important material event.
Sadly like so many events in the past, I fear nothing will come to fruition.