They just need to follow FDA guidelines. The drugs being used individually are already FDA approved. So, this combinational therapy is being conducted for its safety and efficacy. As long as they follow FDA guidelines and "good common practices (GCP)" they should be good to go. They will have an IRB. International Review Board overseeing the each phase. Each phase will be looked at and approved phase by phase. I believe Jim will announce the researcher who will oversee trials. So that will be a PR. Or 8k