The FDA has informed Hemispherx Biopharma Inc. that research on its experimental drug Ampligen is insufficient to support the drug’s approval for treatment of chronic fatigue syndrome (ME/CFS). The FDA has indicated that at least one more study would be required to credibly demonstrate the drug’s efficacy and safety for treatment of ME/CFS, according to a report featured December 1 by CNNMoney.com and news alerts issued by a number of other pharmaceutical & financial market trackers.
According to the reports, the FDA stipulated a number of requirements that further trials should satisfy, including size, duration, and monitoring criteria. Philadelphia-based Hemispherx has indicated it intends to make a prompt response to the FDA's suggestions “its top priority.”
For more on Ampligen’s long history of clinical trials, go to http://en.wikipedia.org/wiki/Ampligen