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FDA Advisors to Consider Ampligen (Rintatolimod) for Chronic Fatigue Syndrome

Preliminary review set for December (Sept. 24)

Hemispherx Biopharma, Inc., based in Philadelphia, Pa., announced on September 24 that the FDA has tentatively scheduled an advisory committee meeting to discuss the company’s new drug application (NDA) for Ampligen (rintatolimod) for chronic fatigue syndrome (CFS). The date of the review has been tentatively set for December 20, 2012. The Prescription Drug User Fee Act (PDUFA) goal for the FDA to complete its review is February 2, 2013.

Recently, the FDA has become increasingly active in working with the CFS and myalgic encephalomyelitis (ME) communities, the company said.

On September 13, 2012, a teleconference organized by Dr. Janet Woodcock, Director of the Center for Drug Evaluation and Research, was held between the FDA, patients, advocacy organizations, and other stakeholders. The FDA explained during the teleconference that it plans to host an Excellency in Advocacy webinar in mid-November 2012 that is intended to “advise patient advocates or advocacy groups on how to come together and develop common themes to ultimately further [their] mutual goals and be beneficial to everyone.”

In the spring of 2013, the FDA also plans to hold a workshop to explore scientific issues about identifying valid, reliable, and measurable outcomes to determine whether disease symptoms improve with intervention.

For more information, visit the Hemispherx Biopharma, Inc. Web site.

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