The FDA then denied approval. Their rationale? The

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The FDA then denied approval. Their rationale? The drug helped "only" 44% of the patients.

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The clinical trial showed p = .047. Statistically significant but barely. With 234 patients in the study the FDA my have wanted a larger trial.

The drug Ampligen is a TLR3 receptor agonist which would boost anti-viral activity. With viruses being implicated in CFS/ME it likely does have some benefit. But would also work against itself in the CFS/ME indication by increasing inflammatory activity.