The FDA ought to have fast-tracked Ampligen for approval based on the phase II results back in 1998. They didn't. This was partly due to the perception that CFS was not a serious disease. Fifteen years later, CFS remains a crushing burden on the economy and no other drug companies have even gotten through a phase II study. There are no prospects for a treatment being approved for CFS in the next five years other than Ampligen. Other treatments being considered are much more dangerous than Ampligen. The agency said no in 2009 but they have a lot of discretion in how strictly they scrutinize drugs. They should consider the burden of CFS on society and the failure of any other drug company to make progress and give Ampligen the benefit of the doubt.