Nearly 4 months after a decision was due, the FDA still has not ruled on whether Ampligen will become the first-ever approved treatment for chronic fatigue syndrome. Last month, the CEO of Hemispherx Biopharma Inc., the drug's manufacture, said that he expected approval this fall. He apparently later said it would be "by" fall -- but now fall is officially here, and there's still no word.
There was talk all summer about what the delay meant -- is there a problem with the New Drug Application? Is there some hidden meaning to all this? Or is the Ampligen decision just one of the many that have been put off while the FDA deals with a lot of changes?
Either way, with no word coming from the company and the FDA legally prevented from commenting on pending applications, it's disheartening to wait ... and wait ... and wait, while people who may benefit from the drug continue to suffer, and while the increased credibility and visibility that can come with the first drug approval remain on hold.
What has the delay done to your hopes of Ampligen being approved? Has it diminished them? Take the poll, and leave your comments below!
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