z_smith: Simply put, there is a provision in the emergency use approval regulations that requires a confirmatory post approval trial as an integral part of that entire process. As far as I know, there is no provision, nor history, authorizing the FDA to require drug companies to interrupt their operations in order to prepare and submit time consuming clinical trial protocols simply because a FDA staffer would like to see one. Under such an approach, FDA staffers would have the right and power to dictate drug company research priorities or face clinical trial holds. That strikes as draconian even for the FDA.

Now, the FDA may well look at CYDY's HIV sub population data and then deny emergency use approval, but if all of this trial protocol and other non safety related info aren't related to an emergency use approval consideration, then there appears to be no regulatory or sensible basis for this major undertaking.

If approval is granted, my guess is that it will be due to data and medical records demonstrating regression by HIV patients after LL was withdrawn from their medication.