Hi Martin, Hope this answers a few of your concerns:
- Hospitals were 'signed up' at the start of the year, it has been their PR departments and many NDAs which have prevented ResApp from declaring the hospitals. ResApp were approached by all three and they have been committed and on board since. Sure it has taken a while to begin the trials, but that is due to many clinical protocal procedures, back end workarounds etc. Yes they misjudged timing. It is ResApps call however to initiate the beginning once every hospital is on the same page, just makes for a more fluid trial.
- Algorithm is allowed to learn during trials, but the self learning component will be turned off as it makes the FDA more comfortable with final results. Trial results should come on par with Australian data if not a few percentage points lower. Anything above 80% will satisfy the FDA criteria comfortably I believe.
- Dr Udantha has not been the sole analyser of the data, more an advisor. Infact there is an entire scientific team at UQ who have been analysing results. In addition, there has been 3 or so radiologists analysing each X-ray to confirm or deny the results from ResApp, remember there is an entire backend too.
- Double blind is standard procedure during any FDA trial of this stature
- The Humanitarian organisation will most likely sign a commercial deal once they have completed the upcoming multicountry study and post US trial results. Dr Tony told me there is no point pushing before that, the WHOs work at their own pace and having US clinical data will only bolster their negotiating ability instead of trying to sign a half cooked deal now. They will come on board once all the ducks are lined up.
Cheers
Doubts, page-8
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