How Important is the USA Market and so FDA

We all "know" that a large part of SPL's commercial success with VivaGel and so share price going forward is to do with successfull selling in in the US which relies on an FDA approval. Does the US make up much of the World market for pharma products? Looking at some 2017 data I see that the USA Pharma market is far larger than any other region, in fact the data I have shows it worth 339billion/year compared to number 2, Japan at 94billion/year.

In fact, the top 9 phrama sales regions, ranked 2 to 10, have total sales valus of 387billion compared to USA alone with 339billion.

YES, we are heavily reliant on success with FDA and in the USA. To me it looks like SPL Management are on to it.