I agree with 90% of the above apart from the fda points 

The fda set a ridiculously high bar, and often require high quality randomised controlled trials which is partly why most quality drug companies ser up their trials to pass the fda requirements (and the us market is big and lucrative)

given how long penthrox has been around for, I doubt there is any recent high quality phase 3 rct studies? I believe mvp are trying to run some now - but big trials need big funding costs that mvp may be a bit cheap to pursure????

this would not be the first drug the rest of the world considers standard of care but is unavailable in the usa

still a fan of mvp and looking to buy again, but sold out a while ago due to valuation. That and the fact I couldnt figure out when their patents might run out given how long the drug itself has been around for

but the fda looks like they will want a big (costly) trial