http://www.bizjournals.com/philadel...-biotech-hemispherx-biopharma-settlement.html Exerpt: A Philadelphia biotechnology company has tentatively agreed to pay $2.75 million to resolve a lawsuit brought by its shareholders, who allege the company made “material misrepresentations and omissions” regarding the status of a new drug application for its lead new drug candidate. The class action lawsuit was filed against Hemispherx Biopharma, which has spent more than three decades developing Ampligen for a variety of possible uses. It is currently studying the drug’s potential use as a therapeutic and preventative vaccine enhancer. In 2007, Hemispherx filed a new drug application for Ampligen seeking to market the drug as a treatment for chronic fatigue syndrome. The Food and Drug Administration rejected the application in 2009 saying the clinical data submitted did not provide “credible evidence” of the product’s effectiveness. The agency suggested Hemispherx conduct an additional clinical study for Ampligen. Instead Hemispherx (NYSEMKT:HEB), in 2012, submitted additional analyses of data from a previously conducted clinical trial as part of its response to the concerns raised by the FDA when it rejected the Ampligen application. In early 2013, the FDA once again rejected Hemispherx’s application for Ampligen — after an advisory panel voted not to approve the drug in December 2012 — stating data submitted with the application did not provide substantial evidence of Ampligen ‘s effectiveness in treating patients with chronic fatigue syndrome, or sufficient information to determine whether the drug was safe when used to treat patients with the condition.