Hemispherx Biopharma, Inc. (NYSE Amex:HEB) (the "Company" or "Hemispherx"),
announced that it received a Complete Response Letter from the U.S. Food and
Drug Administration ("FDA") which describes specific additional
recommendations related to the Ampligen(R) NDA. In accordance with its 2008
"Complete Response" procedure, the FDA reviewers determined that they cannot
approve the application in its present form and provided specific
recommendations to address the outstanding issues
Ampligen vs.Asensio in the Wall Street Journal :This
article describes the financial battle between the manufacturer of Ampligen
and financial short-seller Manuel Asensio, as reported by the Wall Street
Journal, Monday, June 26, 2000. Ampligen is an experimental drug being
developed for treatment of chronic fatigue syndrome and HIV and other
diseases.
Ampligen [polyI:polyC12U] is a mismatched double-stranded RNA that acts by
inducing interferon production (immunomodulator) and by activating an intracellular enzyme (RNase-L) against
viral RNA transcripts (antiviral).