Koo,
As per various company communications, there is an interim sample size re-estimation analysis (SSRA) at 75% of the planned 250 events, which would correspond to 188 events. This is the only SSRA that the company has indicated. So the idea of an arbitrary end of year analysis just because it is the end of year seems unlikely and unjustified. Besides SSRA at 188, no other interim analysis has been discussed other than the period DSMB safety reviews, which we have had six of so far. So there are a few possibilities (not an exhaustive list):
1) SSRA happens at 188, top line at 250.
2) SSRA is not done. Top line data at 250
3) SSRA is re-scheduled for some point beyond 188 but before 250. Top line at 250.
4) SSRA results in increased sample size and number of required events. Top line at ?
BearDownAZÂ
