Hemispherx plays the FDA waiting game

Hemispherx Biopharma says the FDA, citing an increased workload, has extended its review for Ampligen for the treatment of chronic fatigue syndrome. No drug candidate has received FDA approval for the treatment of chronic fatigue syndrome, but supporters remain confident in the drug's potential.

Kim McCleary, president and CEO of the Chronic Fatigue and Immune Dysfunction Syndrome Association of America, tells the Philadelphia Business Journal that the group remains optimistic that the FDA will find Hemispherx's data sufficient for an approval. "If it is approved, it is expected to be quite expensive," McCleary said. "[Ampligen] has shown to be effective in certain subsets of the condition... If they get an approval, we think other companies will follow them in and it will lead to more research."

It has taken Hemispherx some time to get to this stage. The company began as HEM--a Maryland-based contract services company that primarily provided research services for the NIH and NASA. It was reorganized into a drug development company in the 1980s. Since then, the company has fired and rehired its CEO (who co-invented Ampligen), battled with a Wall Street shortseller after going public and avoided an alleged hostile takeover, the Business Journal reports.

The original compound for Ampligen was discovered at Merck in the 1960s. The drug candidate Ampligen has has been under development for over three decades and has been studied as a treatment for a range of diseases, including AIDS, cancer and the avian flu.

As of September 30, Hemispherx  had an accumulated deficit of $182.5 million, according to its latest SEC report.

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