The company's biggest push has been in chronic fatigue syndrome, a poorly understood disease with no known cause that starts with flu-like symptoms and progresses to chronic weakness and fatigue (hence the disease's moniker.)
Hemispherx submitted Ampligen to the FDA for approval in October 2007. An approval decision date of Feb. 25, 2009, was extended to May 25, 2009. But that date came and went with no word from the FDA, although Hemispherx claimed the agency requested "one or two more weeks" to make a decision. That short 14-day delay eventually stretched for seven months, culminating in Tuesday's announcement.
-- Reported by Adam Feuerstein in Boston