"if the algorithm changes in the future, I am certain that the trials will not have to be re-run"
The trial is a comparison of the results of expert diagnosis in the traditional manner in the hospital against the diagnosis by the Resapp app. The hospital does both sets of tests on the same patient then someone independent compares the results.
Once you have those trial results you will have a database of cough signatures with the expert diagnosis (and only Resapp holds both). That database from the trial becomes extremely valuable, because every time you tweak the Resapp algorithm you can test it against the database results in a second and you can see whether there is an improvement in the results. There is no need to do another clinical test unless you want more data.
If you compare it to Olympic drug testing, they take a sample at the Olympics and test some of the sample against current drug testing technology. They keep some of that sample in the freezer for the future. If detection technology improves in the future, they pull the samples out of the fridge and retest them. They can do this over and over again until they run out of blood samples. With Resapp though they never run out of samples because the sample is a digital signature which can be kept for ever and tested over and over again.
Whether or not though the FDA would require you to submit the updated App every time you tweak it though is another question that I don't know the answer to. At least if they require that you would not have to do the clinical trials and it would be around 3 months only to get approval while at the same time you have a working product that is making money.
RAP Price at posting:
43.5¢ Sentiment: Hold Disclosure: Held
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