Good point when you want to compare china and India together to US there numbers are too high in Asia and definetly a bigger market but the profit margin could be higher in US compared to India and China where the profit margins won't be so high due to state controlled drugs pricing...so I wud still consider US a lucrative market and it's approval will pop the price for sure how high we need to see some analysts coverage...jmho
FDA approval is a stamp of quality and prestige for a medical drug/device. It is very important. People in other countries are more likely to approve the device and more likely to purchase it just knowing the FDA has validated the clinical data that supports its applications.