Five years after filing for an approval of the chronic fatigue syndrome drug Ampligen, the FDA has spurned the application again, asking for additional information and another clinical trial. Hemispherx ($HEB) said it is planning a formal appeal, chiding the agency for its position on the drug and asserting it had all the data it needed to prove efficacy and safety.
The agency last rejected the drug in 2009, after 20 years of research work. A recent internal FDA review, though, was sharply critical of the company's work, noting multiple problems with the application. And the company has come under intense criticism from some analysts, including TheStreet's Adam Feuerstein, for the way it has characterized its relationship with the FDA.
The biotech noted today that it had been told of a hunger strike being mounted by one CFS protester.
"Hemispherx has asked any hunger strikes be discontinued and that patients join in a collaborative effort between the FDA, Hemispherx, CFS clinicians and patient advocates to find a solution to this significant unmet medical need," the company said in a statement.
The biotech's shares were down 5 cents this morning, trading at 21 cents.
- here's the release