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Ampligen phase 3 trial is coming
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I thought I might spread a little hope today.

Ampligen is a medicine that has the potential to significantly improve ME/CFS. There are many well documented cases where it helped people go from bedbound to moderate or better. Clinicians who use it have reported that 50 to 70% of severe patients significantly improve on it.

The FDA rejected Ampligen back in 2013 asking for a further confirmatory trial. AIM Immunotech, the drug company, has been reporting that it is developing a protocol for a confirmatory phase 3 trial. According to its quarterly reports they initially aimed to file a response to the FDA rejection by end of last year. Obviously that timeframe has slipped a bit.

Ampligen is a highly controversial drug. The FDA rejected it because the last round of phase 3 trials failed to show, to a statistically significant degree that Ampligen worked. The trial was poorly run with the FDA complaining about data gaps.

But I choose to hope. Ampligen clearly works in some people, though the results aren't universal. Maybe this second clinical trial will be better designed and able to demonstrate efficacy.

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2 years ago