Hi ejwalk, I believe RAP has shown itself as de-risked since the pre adult trials of an accuracy of 100% following the paediatric results of 90% -95% for the 2 diseases here in Australia. plus with the US hospitals testing for the same dieases it will (or should because its a self learning algorythm) only enhance the results.
And specifically because they have FDA consultants Experien Group who have achieved a 99% approval rate for regulatory submissions. The senior staff have been responsible for over 1,000 successful FDA and international regulatory submissions over their careers. They have extensive experience in Premarket Approvals, 510(k) and de novo applications, including submissions for mobile medical apps. In 2015, Experien received FDA 510(k) clearance for a software product that performs personalized physiological analytics using machine learning algorithms.
(from RESAPP website re: FDA Consulant engagement)
but of course that doesnt mean they have it nothing is guranteed it all about the risk I'm prepared to take RAP could be part of the 1% that Experien don't get throu to FDA approval. but I do like the odds of 99 to1 that they will have a great weekend
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