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
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).