Hemispherx Biopharma, Inc. (AMEX symbols: HEB and HEBWS) (Price: $6.00) has misrepresented Ampligen’s clinical trial results and its Food and Drug Administration (“FDA”) filing and approval status. In a letter dated September 30, 1998, Asensio & Company, Inc. informed the FDA of Hemispherx’s numerous false claims regarding the FDA’s evaluation of Ampligen’s safety and efficacy as a treatment for Chronic Fatigue Syndrome (“CFS”). Our letter to the FDA’s Center for Drug Evaluation and Research and the Director of Compliance, is available on our internet site located at www.asensio.com. The letter cited statements made by Hemispherx’s chairman, Dr. William A. Carter, during an investor conference call on September 23, 1998. We believe these statements constitute a clear violation of the FDA’s pre-approval drug promotion regulations.
Dr. Carter has misrepresented Ampligen’s very limited IND cost recovery status in an attempt to cause investors to believe that the FDA has reviewed its clinical trials and has approved Ampligen’s efficacy and safety in treating CFS. In addition, Dr. Carter stated during the call, “Probably between 100 to 150 federal scientists have examined this data over time and have all found the data to be promising and worthy of investment, worthy of treatment status and worthy of being sold to United States consumers at a price of $7200 for a six month treatment.” Dr. Carter also asserts in the call that Hemispherx “is allowed under the law to sell its drug.” This is a completely false and fraudulent misrepresentation of Ampligen’s FDA status .
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