PHILADELPHIA --Three years after being rejected by U.S. Food and Drug Administration, Hemispherx Biopharma (HEB) is back seeking regulatory approval for Ampligen, its controversial therapy for chronic fatigue syndrome.
Everyone loves a comeback story with a happy ending, but Hemispherx's second attempt won't turn out any happier than the first. FDA is likely to reject Ampligen again because Hemispherx ignored the agency's demand to run a new clinical trial in chronic fatigue syndrome.
Instead, Hemipsherx has spent the past three years doing essentially nothing but re-analyzing data from the old Ampligen phase III trial completed in 2004. FDA reviewed the original study already, deeming it "lacking credible evidence of efficacy of Ampligen."
Sentiment: Strong Sell
Hi pharmaherobm (or pharamherokl - why do you use two IDs?) -
Before writing such a humbug you should first look up what a Ponzi scheme is...
I have a suggestion for you: fill in the application form (it involves some killing of yourself - as you are a hero, no problem!) and then apply for a Darwin award! The world's gene pool would be better off without you.
Sentiment: Strong Buy