The market only cares about FDA so yes your right, this is FDA...

The market only cares about FDA so yes your right, this is FDA make or break... (Barring left field announcements about TGA/CE approval or 3rd world contracts)

Given SP went to 55c (then declined steady at 30+c) in anticipation that the app might be approved by FDA for pediatric 0-12 year old use only, what would have happened to SP once approval was granted? Thats just Pediatric use...

Now consider from the above SP theoretical base, what would have happened to the SP once FDA approved for for use in adults. The revenue potential immediately increases by 300-400% as it opens the user base to not only children but the entire population.. what then would the SP do?

This would have been the ideal situation, a  gradual increase in SP over time... We are now in a curious situation where we potentially go directly to Pediatric and Adult FDA approval at the same time - immediately rather than gradually...

Management have identified the issues with the clinical trials and have moved to address them.