For many ME/CFS patients, Ampligen offered a glimmer of hope for an effective treatment. New developments which I've been monitoring however pour some cold water on the flame of hope that was burning for ME/CFS sufferers. In an unexpected turn, the FDA has demanded additional data from Hemispherx Biopharma regarding safety data, and to perform additional clinical trials regarding its efficacy. This did not bode well for the securities regulators, and shareholders, who filed suit claiming that it's CEO Bill Carter provided misleading information regarding Ampligen's regulatory status.
Something of this magnitude is by no means unheard of in the pharmaceutical company - Supergen's CEO Jon Rubinfeld was involved in a similar controversy with the drug Orathecin to treat pancreatic cancer. It certainly will have a profound impact on the approval process for Ampligen. Given the current situation, an approval for the drug should not be expected until Q3 2010 at the very least. Given the litany of lawsuits Hemispherx potentially faces, it could very well derail the Ampligen approval process, and bankrupt the company. Hopefully, if this is the case, one of the pharmaceutical giants picks up Ampligen, and does the proper filings.
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