I would be looking at the total matched data pairs to date which are 354 and 40 patients in total. Whilst only 17 patients in this trial, they have been extensively tested in different scenarios:
“The ability of the App to discern between pain on movement and pain at rest was measured by comparing scores before and after a potentially painful event such as movement in walking, repositioning and toileting."
Measuring current pain levels with the ABS I could imagine would be very difficult under these conditions.
ResApp to submit for FDA approval need around 400 patients but are continuing trials as the app only becomes more accurate with increase data sets and coughs.
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