There wasn’t any magic to our success. It was a matter of patiently adapting to changes, communicating clearly and frequently with all concerned, and maintaining our focus throughout. It also helped that we had regulatory specialists in each country to handle submissions on their home ground. As a result, we were able to balance the need for unusual flexibility with steadfast adherence to high ethical and scientific standards. It all goes to show: Good problem solvers are good at solving problems that are very different from the norm.