FDA: Hemispherx Must Complete At Least One More Ampligen Trial

The FDA has issued a complete response letter (CRL) for Hemispherx Biopharma’s chronic fatigue syndrome (CFS) drug Ampligen, requesting at least one more clinical trial, various nonclinical studies and a number of data analyses. Hemispherx’s application did not provide substantial efficacy evidence for Ampligen (rintatolimod) and did not provide enough information on the drug’s safety, the letter states.
Washington Drug Letter