Positives

• In Dr. Daniel Peterson’s pioneering 1990 cohort, after 24 weeks of Ampligen most of the 15 severely-disabled ME/CFS patients showed increased performance status and exercise tolerance, with many regaining the ability to perform daily activities with minimal assistance MEpedia.
  
  

Negatives

• An FDA advisory panel voted 8-5 against approval and the agency formally declined to approve Ampligen for ME/CFS in 2013, citing inadequate evidence of efficacy ME Association.
• Patients in the expanded access program have to cover the cost themselves, with one ME/CFS patient quoted at roughly $25,000 a year MEpedia.
• Phase II Long COVID and ME/CFS work has produced mixed signals and the most recent reanalysis still describes the data as questionable Wikipedia.

Hurdles & Side Effects

• Ampligen requires twice-weekly IV infusions in a clinical setting and is not FDA-approved for ME/CFS in the United States — patients have historically traveled to specialty clinics or paid out of pocket under expanded-access programs American ME and CFS Society.