Wednesday, April 20, 2016 4:21:28 PM
the fact that they didnt fully enroll the trial until they hit interim event threshold.
if you were mgt had thought there was no chance of positive interim, you would have fully enrolled reduce it earlier. that way you would get maxiumum curve separation by the end of the trial.
by waiting around to enroll these last patients until after interim threshold was hit management was avoiding being "unlucky" where some recently enrolled patients might be on vascepa for 1 week and have a heart attack. now that the interim threshhold has been hit even being unlucky w a few events probably even out over the next 1.5 years
we know that if there is a interim halt for overwhelming efficacy, it will likely be by a small margin. so every event is needed. if mgt thought there was no chance for interim, they would have enrolled the last patients faster, to get more curve separation over time. since they did not do this and didnt want to be unlucky, they think there is a decent chance for interim stop and were willing to give up a bit of trial power to play that card...
yb
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