Tuesday, February 5, 2013
Hemispherx Receives Complete Response Letter From FDA on Ampligen
Hemispherx Biopharma Receives Complete Response Letter From FDA on Ampligen(R) New Drug Application for Chronic Fatigue Syndro
Readers Digest version: FDA wants more evidence.
At least they're consistent -- for the past 2 decades, I've been hearing every year that Ampligen is 18 months from approval. Never actually gets there.
Yes, I'm frustrated, but I'm also mindful of the politics of the situation:
Osler's Web, p.520 (the 1991 chapter) "Cheney noted, 'The FDA is *really* in a bind. If the agency approves the treatment IND application, they will, in one swoop, destroy the credibility of two government agencies."
As long as CDC says CFS is psychiatric, FDA can't approve a medical drug for it. It's that simple.