Ann: ResApp Submits De Novo Application to the FDA, page-79

Anything above 70% +ve/ -ve agreement as I recall is deemed significant. That is why only those respiratory conditions, chiefly upper and lower respiratory tract infections and pneumonia/broncholitis are submitted. As well it is important to have three or more conditions approved as it means the process for further approvals is a lot quicker and smoother, not having to start from scratch. This is why I believe the latest two Apple product approvals have only taken 1 month as mentioned by a previous poster. If FDA is granted for all respiratory conditions submitted then the Adult trials and applications will be much quicker.