Hemispherx's CFS Drug Is a Long Shot

Besides that, Hemispherx's statement makes no sense because the FDA's Ampligen review is either delayed or it isn't. With the clock now ticking past the scheduled May 25 approval-decision date, the review is clearly delayed, so perhaps it's incumbent upon Hemispherx to provide a better explanation.

I step back and look at the entire picture -- the shifting Ampligen efficacy data, a 5-year-old phase III study that appears to have failed, no clear accounting of the drug's safety, wishy-washy explanations for a delay at the FDA -- and it raises too many red flags.

Ask my opinion, and I'm happy to offer it: Ampligen will not be approved.

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