The FDA is going to hold a little webinar on February 4th an 5th. The following was posted to the federal register on 01/15/2013. Creating an Alternative Approval Pathway for Certain Drugs Intended to Address Unmet Medical Need; Public Hearing The Food and Drug Administration (FDA) is announcing a public hearing to obtain input on a potential new pathway to expedite the development of drugs, including biological products, for serious or life-threatening conditions that would address an unmet medical need. The drug’s safety and effectiveness would be studied in a smaller subpopulation of patients with more serious manifestations of a condition. Such a pathway could involve smaller and more rapid clinical trials than would occur if the drug were studied in a broader group of patients with a wide range of clinical manifestations. The labeling of drugs approved using this pathway would make clear that the drug is narrowly indicated for use in limited, well-defined subpopulations in which the drug’s benefits have been shown to outweigh its risks. The purpose of the public hearing is to obtain information and comments from the public on the need for and feasibility of this pathway and its potential advantages and disadvantages. Full posting here: https://www.federalregister.gov/art...-drugs-intended-to-address-unmet-medical-need This fits CFS and Ampligen to a "T". We know that members of AdCom were calling for the FDA to get "creative". We know that ampligen did not quite fit the FDASIA requirements (they needed a surrogate endpoint). We know that a large trial would be very difficult, given the nature of the disease, and associated problems. I think the FDA may get it. This could change everything.