There were some patients paying $25,000 per year for twice weekly infusions of this drug who testified to the committee that Ampligen helped them greatly, but this could not be widely replicated for the broader population of ME/CFS patients in the small studies that were done.
posted on 12/23/2012 9:20:29 PM PST
(Defend aircraft from "runway kill zone" mini-drone helicopter swarm attacks: www.runwaykillzone.com)
To: Monkey Face
posted on 12/23/2012 9:21:41 PM PST
by null and void
(Going Galt: The won't of the people)
Key deficiencies included inadequate evidence of effectiveness or safety, inadequacy of drugdrug interaction studies, lack of carcinogenicity assessment, lack of anti-drug antibody determination, and inadequate analytical methods and drug product specifications, the agency wrote in one of several sections listing problems associated with the application.
Those are some pretty large deficiencies. That paragraph suggests that large-scale clinical studies were not done, but they were trying to push the drug through to approval anyway? Gee...
posted on 12/23/2012 9:40:10 PM PST
(Now that I've finally accepted that I'm living a bad hair life, I'm more at peace with the world.)
They thought approval was certain when the control group made it through an entire hour of PBS broadcasting without falling asleep.
posted on 12/23/2012 9:50:02 PM PST
(Sarah Palin got more votes in 2008 than Mitt Romney got in 2012)
FreeRepublic.com is powered by software copyright 2000-2008 John Robinson