Monday, September 22, 2014 10:44:20 AM
It is the main difference between us (and it is a big error in the SPA). The SPA does not contain anything about what is necessary for the determination. It’s about the determination itself.
"A clinical protocol assessment will no longer be considered binding if the director of the review division determines that a substantial scientific issue essential to determining the safety or efficacy of the drug has been identified after the testing has begun."
"The FDA has revaluated the situation and has adopted a more conservative approach than previous applied for biomarker based approvals targeted towards cardiovascular risk reduction." (from CC transcript)
Agree w u, the determination is wrong, but they have a legal background to determine.
As the “the magnitude of the changes in several lipid and lipoprotein parameters, as well as biomarkers of inflammation, between baseline and Week 12 in the placebo group are rather atypical for lipid-lowering trials.” it was not special. ANCHOR was about lipid-changes and short-term (12 weeks), meanwhile R-IT about hard outcome and long-term study. To ignore the R-IT result the placebo group has to show abnormal, high event rate (btw: in this case the study will be stopped earlier due to safety reason) changes in several lipid and lipoprotein parameters (if any as it is long-term) will not be enough.
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