Voclosporin will likely be approved well before the P3 trial runs it course. Here's how it's going to work. First, there's a legal and regulatory path for this approval . While I quote the relevant passage below, here's the link to the FDA Regulations , as well as a list of drugs t hat received accelerated approval. Sec. 314.510 Approval based on a surrogate endpoint or on an effect on a clinical endpoint other than survival or irreversible morbidity. FDA may grant marketing approval for a new drug product on the basis of adequate and well-controlled clinical trials establishing that the drug product has an effect on a surrogate endpoin t that is reasonably likely, based on epidemiologic, therapeutic, pathophysiologic, or other evidence, to predict clinical benefit or on the basis of an effect on a clinical endpoint other than survival or irreversible morbidity. Approval under this section will ...