The Food and Drug Administration (“FDA”) authorized Hemispherx Biopharma, Inc.’s (AMEX symbols: HEB and HEBWS) (Price: $7.00) (“HEB”) Ampligen CFS Phase III clinical trials on October 9, 1992. This means that Hemispherx’s approval to conduct Ampligen’s Phase III CFS tests is over six years old and not, as the company has attempted to make investors believe, a new major development. In this six year period Hemispherx has failed to conclude the Phase III trial. This has allowed Hemispherx to promote its stock based on fraudulent misrepresentations of a flawed, 7 year old Phase II trial.
Furthermore, in December of 1993 the FDA designated Ampligen as an Orphan Drug. Hemispherx requested the orphan drug status. Approval is based on the confirmation that CFS is a rare disease that affects less than 200,000 persons in the United States and that there is no reasonable expectation for Hemispherx to recover its cost from sales in the US. We believe that both the 1992 Phase III approval and the 1993 Orphan drug designation provide clear and convincing evidence that Hemispherx’s representations concerning Ampligen’s CFS sales potential and FDA approval status are entirely false and misleading.
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