There's nothing relevant about FDA success if approval already exists in Europe, don't you think? Certainly not "exceptionalism." FDA approval would only mean furthering success.
It also ignores the company's own stated strategy:
Strategy Develop and test drug candidates in animals, then file data with the FDA for permission to move to human trials. We will consider licensing each drug after the completion of Phase 2a human trials
Revenue / Funding Spent $17M in 5 1/2 years with 9 drugs in pipeline of which there are 5 lead candidates for eventual FDA submission. At historical spending levels, the Company has 3 years of cash in the bank although the path to the FDA will require increased expenditures on a monthly basis.