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Wednesday, August 17, 2016 5:23:25 PM
1) If primary endpoints are met, then secondary endpoints may lend weight to pinpointing mechanism/MOA that are the foundation(s) of primary endpoint success. For instance, RRR of xx% appears due largely to these factors: (such as EPA/AA ratio, other biomarkers, etc.) This gives AMRN extra leverage with FDA if they accept DMC's recommendation to stop the study.
2) If primary endpoints are not met, then secondary endpoints may indicate success in certain subgroups, which may or may not validate partial stoppage for a group; or may provide AMRN with extra study time for RRR success to meet stoppage goals (as pointed out by others).
There are likely other strategic advantages to the creation of secondary endpoints, but I doubt AMRN would have agreed to these additional factors if they did not feel confident that they stood a good chance of meeting secondary endpoints. Nobody's going to put together a $xxxMillion dollar study and create secondary endpoints that are likely to fail.
I won't opine on the strategy behind 2nd interim look, as that is a separate topic.
Recent AMRN News
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