Without getting a direct answer from the company one can only make an assumption. Mine currently, be it right or wrong, is that drugs used in a STUDY that have not yet been FDA approved cannot be given LEGALLY to anyone outside an authorized study. That even includes participants in a now close PHASE trial that have and could benefit from continued use of a developmental drug. That may seem a bit harsh but laws and regulations are in place to protect us even if at times they do not. This is of course an OPINION as I am not up on FDA regulations. Am hoping I am missing something.