Phase 3 will be fast and relatively speaking cheap. The FDA has given guidance for what they want, and you can bet that the EU will not be MORE restrictive -- they have always been LESS restrictive.

Unlike clinical trials for cancer and other complicated diseases, patients dosed in this trial will exhibit results within weeks. And it's going to be lots easier to recruit patients now that we already have a demonstrated reduction of OM because of the success of the Phase 2 trials.

I expect the trials to commence quickly and to have results quickly.