I agree with your assessment.
The problem seems to be that some people with CFS are helped by Ampligen, but they don’t yet know why they are while most others are not. That is not a strong enough result for an FDA approval, but Ampligen did get 4 votes out of 15, so it wasn’t a total washout.
Some studies indicate that there are as many as five sub-categories of illness lumped together as CFS and some might be more responsive to Ampligen than others, but the studies haven’t been done. At $25,000 per year for the drug it takes big bucks to fund a study big enough to persuade the FDA, if successful.
What, does the FDA demand less expenditure on studies if the marketer of the drug only plans to charge a low price for it?
(That’s what your comment sounds like.)
My Mom was afflicted by CFS this past year and we all thought she was a goner as she was sleeping 20 hrs/day. Her recovery was remarkable but took 3 months of Famvir before she started to perk-up.
Syndromes are called that due to no one specific etiology. Treatment for "syndromes" are more difficult to assess for efficacy due to the multiple etiologies. For CFS the antibodies to the viruses are all over the place and symptoms can improve with titers remaining high.
Not aware of the clinical studies with Ampligen but it is hard to imagine how they did not collect the data needed for FDA review.