FDA Forward-Looking Events

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Hemispherx Biopharma Announces FDA Confirms Advisory Committee Meeting on December 20, 2012
Date : 10/22/2012 @ 8:49AM
Source : GlobeNewswire Inc.
Stock : Hemispherx Biopharma, Inc. (HEB)
Quote : 0.4801 0.0 (0.00%) @ 2:05AM


Hemispherx Biopharma, Inc. (NYSE MKT:HEB) (the "Company" or "Hemispherx") today announced that the U.S. Food and Drug Administration ("FDA") has scheduled for December 20, 2012 a meeting of the Arthritis Advisory Committee ("AAC") to discuss the Ampligen® New Drug Application for Chronic Fatigue Syndrome ("CFS") which is currently under review by the FDA. As previously announced, the Prescription Drug User Fee Act ("PDUFA") review goal for the FDA to complete its review is February 2, 2013.

The AAC meeting will be held from 8 a.m. to 5 p.m. at the FDA White Oak Campus, 10903 New Hampshire Ave., Building 31, Conference Center, the Great Room (Room 1503), Silver Spring, MD 20993-0002. Further details are available at https://federalregister.gov/a/2012-25878.

The announcement of the December 20, 2012 AAC meeting follows the FDA's September 13, 2012 teleconference on CFS and Myalgic Encephalomyelitis ("CFS/ME"), the transcript of which is available at http://www.fda.gov/downloads/Drugs/NewsEvents/UCM320310.pdf. In addition, on October 25, 2012, the FDA is holding a public meeting to discuss the patient-focused drug development initiative, one of its performance commitments under PDUFA V, which is intended to establish a more systematic approach to obtaining patient perspective on certain diseases. CFS is one of 39 diseases nominated for such review. Also, in the Spring of 2013, the FDA is scheduling a workshop on the development of treatments for CFS/ME.