HL - If there is only 100 events we will have a very long wait ahead of us. The SSRA is being done at 188 events or 75% of the way through this 250 event trial. 

Now more seriously 

We should hear one of 3 answers

1) Stop the trial - if there is no real difference between the standard of care placebo group and the dosed group and or there are safety problems with the dosed group. No real difference equals somewhat less than 25% RRR which would require a much larger patient population for statistically significant numbers if there are no safety issues.

2) Add more people to the trial. In this case 1200 people would be added to the trial. As it is designed now the trial is powered to give statistically significant results for a 30% RRR and by adding 1200 people it would be properly powered to give statistically results for a 25% RRR. In this scenario there are no safety issues.

3) Continue on the way you are. In theory this would mean that there is at least a 30% RRR as that is the % required for the power of this trial design for statistically significant numbers and there are no safety issues.

I wouldn't expect much more commentary than Stop, Add or Continue from the DSMB as this double blinded trial is not yet complete.

#3 is what we want to hear with no explanation.

As I understand the trial design.

tada