The other thing that I have tried to quantify, is how much of a boost to Penthrox sales can be expected from paediatric approval in Europe.
Frustratingly, there is no data about what percentage of penthrox use in Australia is for children. Claude's best guess is 10 - 20%, but with poor data and high uncertainty.
Worldwide, only around 10% of ambulance call outs are for children. Plus penthrox is only targeting children aged 6 - 12, so that will be quite a lot less than 10%. But on the plus side, children are relatively more likely to present with trauma than adults. And devices providing pain relief without needles are relatively more attractive in children. Plus there is likely a familiarity effect, whereby the more opportunities medics have to use a device or treatment, the more comfortable they become with it and the more they use it. So availability in children might help drive increased adult use as well over time.
So the upshot is, paediatric approval is likely IMO to provide a significant, but not game-changing boost to penthrox sales in Europe. My best guess, conservatively, is somewhere in the 10 - 15% range.
Currently Penthrox sales in Europe are in the ballpark of $9 million per year. So maybe you could expect around $1 million extra annual revenue, although it might take several years to arrive.