Not that im aware of. The health Industry doesnt a have a worldwide FDA, or federal government so to speak. Its mainly left to the countries, who I guess would count as states, to keep the simile going lol. So its possible they could report international revenues pre FDA approval, but may wait for the patents to be approved to do so. With something this big at stake im sure they want to make sure they are protected as much as possible and go thru all the steps correctly the first time. Thankfully we have a friggen juggernaut of a human in Mr. Hershman to navigate those waters.
As far as each country having their own FDA, im not entirely sure. I think many countries allow FDA approval to be their own standard and in many cases foreign governments are more progressive and evolved on stem cells then even the FDA. Even so im not sure the IP is the final approval needed or if local steps must be taken. Im sure someone has those answers here.
So, in closing, I am obviously clueless ;)
GLTU