Hemispherx Biopharma, Inc. (AMEX symbol: HEB) (Price: $7.625) issued a press release on October 23, 1998 titled “Hemispherx Complying with FDA Request.” This press release failed to disclose that the U.S. Food and Drug Administration (“FDA”) has found that Hemispherx’s Ampligen safety and efficacy statements contained in a press release and on its Website, and in statements made by Dr. William A. Carter during an investor conference call violated federal drug regulations. The press release also failed to disclose that the FDA has instructed Hemispherx to “immediately discontinue the dissemination of materials that make claims of safety or efficacy for Ampligen.” Furthermore, the press release failed to disclose that the FDA determined Hemispherx’s statement claiming that Ampligen’s Phase II CFS study showed efficacy and safety also violated federal drug promotion regulations.
Hemispherx’s press release stated that it received the “Notice of Infraction” from the FDA on October 22, 1998. The Notice of Infraction is dated October 15, 1998 and states that it was “transmitted via facsimile.” Hemispherx issued its defective infraction press release at approximately 6 p.m. EST on Friday, October 23rd. We believe that Hemispherx received the Notice of infraction on Thursday, October 15th and purposely withheld disclosure until after the close of business on Friday a week later. We further believe that Hemispherx’s infraction press release provides clear and convincing evidence of its willingness to issue false statements for the purpose of defrauding investors.
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