>How do you think FDA will react if the new 9902b trial fails to show a statistically significant benefit, but upon 56 more deaths that it swings the p-value to below the magical 0.05 level. Will you be certain that FDA will reject study 9902b altogether?<
I don’t think the 360-event data will have any bearing whatsoever on the FDA’s decision making. I’m astonished that you think it may.