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To: Seizethecarp
“Key deficiencies included inadequate evidence of effectiveness or safety, inadequacy of drug–drug 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...

4 posted on 12/23/2012 9:40:10 PM PST by exDemMom (Now that I've finally accepted that I'm living a bad hair life, I'm more at peace with the world.)
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To: exDemMom

I agree with your assessment.

The problem seems to be that some people with CFS are helped by Ampligen, but they don’t yet know why they are while most others are not. That is not a strong enough result for an FDA approval, but Ampligen did get 4 votes out of 15, so it wasn’t a total washout.

Some studies indicate that there are as many as five sub-categories of illness lumped together as CFS and some might be more responsive to Ampligen than others, but the studies haven’t been done. At $25,000 per year for the drug it takes big bucks to fund a study big enough to persuade the FDA, if successful.


6 posted on 12/23/2012 10:44:49 PM PST by Seizethecarp (Defend aircraft from "runway kill zone" mini-drone helicopter swarm attacks: www.runwaykillzone.com)
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