Fibro Daily

FDA Questions Phase III of Rintatolimod (Ampligen)

Fibro Daily December 18, 2012

Food and Drug Administration (FDA) reviewers are suspicious about the results and conduction of the way Phase III drug trials for chronic fatigue syndrome (CFS) drug rintatolimod (Ampligen). This is due to how the data was valued.

Also in question:

  • 24 weeks of missing data from the trial.
  • A lack of an analysis plan written at the time of analysis.
  • Protocols being changed during the trial.
  • why the study was stopped short without enrolling a full amount of patients.

There is also problem with this trial in relation to what constitutes a diagnosis of chronic fatigue syndrome.

And finally and perhaps even most alarming, the safety data about the drug has been compromised, with the FDA nothing that serious adverse affects were not tracked, coded correctly, or defined correctly.

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