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2012 FDA Committee Mtg.

In December 2012, we paid expenses so that 7 patients and a PANDORA Org representative could give public comment to a U.S. Food and Drug Administration committee considering Ampligen as a drug for ME/CFS.

The committee and the FDA did not approve the application but urged the company to do further studies.

FDA officials said they were "overwhelmed" with the 750 comments they received before and during the committee meeting.

Thanks to our advocacy and the patient comments, some committee members came to recognize the patient desperation to have a treatment that will improve their quality of life. Also, some committee members said the drug appears to be effective for some patients.
Our documents related to the Ampligen application:


Our Activities in relation to the Ampligen application:

  • Hosted an Advocates Extraordinaire™ training webinar on how to be more effective in advocating to the FDA committee.
  • Spoke to the committee about how severely debilitating ME/CFS can be.
  • Sponsored others who spoke to the committee, including Michael Walzer, Dr. Michelle Backus-Walzer, Laurel Wright-Feighery, David Marshall,  Cheryl Marshall and Matina Nicholson.
  • Provided a meal for the patients the night before the committee meeting so they could encourage each other and share their strategies.

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