As someone unfamiliar with the pharmaceutical market: the USA is obviously the most significant market area, but if getting a drug approved for sale there is very difficult, what is the situation regarding China and Europe?
Would it be (or have been) easier to get the drug to market first in Europe and, say, China, and then use that cash flow to provide more time to deal with the FDA’s complexities? Or is it exactly the opposite—meaning it’s easiest with the FDA, and their approval almost automatically opens doors for sales permits elsewhere in the world?