So I think that if the FDA insists on additional studies, it effectively kills the development of this drug. What is not clear is what are the politics behind that decision, at the FDA and in turn at Gilead. Fortunately, Gilead has said that it will continue its compassionate use program. But no company can do that indefinitely if the drug is not being developed. There was a dose response in viral culture negativity, but the high dose was not better than the low dose in lesion healing or pain relief.
Tissue healing is very complex.
And there were more patients on the high-dose group who had complete lesion healing. The results we saw were statistically significant, and were clinically meaningful, in a disease for which there are very few other treatment options. You need something to keep the drug on the lesion, to allow for gradual absorption. If you just pour on the IV fluid, it runs off. There was just one study with a fairly small number of patients.