Upcoming catalysts, page-163

"Are we using the same results from Oct 2018 that spooked the market and plunged the SP by 60%?"
Yes we are. Those results spooked the market because we had been told that the operational issues behind the earlier awful results had been resolved, and we therefore expected that the trial results would be in line with the Australian results. They weren't. Spooky! Shocking in fact. But on closer analysis this looks like the best we're going to get in the US against the adjudication standards available. The indications are that in the US the adjudication is less intensive than in the Australian trials, therefore the adjudicators were less accurate, therefore they were less predictable based on inputs, therefore the algorithm had less success in predicting them

"Is there a small/large chance of RAP not getting FDA clearance due to the weak results?"
Yes, and no. There has always been a small chance of not getting clearance, but if that happened I think it would not be entirely due to weak results. As mentioned by @Brunzy88 having the submission backed by Experian is a big boost for my confidence.

"The Doctors could only agree 66% of the time if you remember in the conference call. We are scoring above 70%"
This is false reasoning, but it keeps resurfacing as new posters arrive and make the old mistakes. You have made the assumption that both the adjudicators and the algorithm are being measured against some other absolutely correct diagnosis. But there is no such thing! There is only the adjudicators and the algorithm. So at best the above statement can be interpreted as saying that the doctors were only right 66% of the time, and ResappDx agreed with the adjudicators 70% of the time. In the 30% of cases where ResappDx disagrees with the adjudicators we have no way of knowing which was correct.

And in any case, saying that the adjudicators could agree 66% of the time is certainly not the same as saying they're correct 66% of the time.