Hi @bullraider007 you raise some interesting points and I...

Hi @bullraider007 you raise some interesting points and I appreciate reading constructive feedback rather than ramping up/down.

Yep certainly FDA is currently out of the question as the pre-defined end points of 75% are unlikely to be met. However.
- Bronchilitis did meet the criteria and it is possible to submit for FDA also possibly Asthma.
- We await outcome of the case by case analysis to see exactly whats going on
- TGA and CE mark are certainly not off the cards. TGA does not reuire US clinical trials, neither does CE mark (but obviously would be good to have). They will require blind trials - which previously weren't done for Aus studies, but wasnt their approach changed to match the US centric model hence probably satisfying TGA/CE guidelines?

Revenue can be generated by TGA and CE mark given the above. Also third world countries could potentially sign a contract based on TGA/CE mark doesnt need to be FDA.

To say its not possible to commercialize the app without a 2nd trial is not entirely correct, but I do understand the rationale for saying it.
Happy to be corrected if anything I said above is incorrect.