I can’t remember who said it. But I believe someone said the reason they thought that the trial was extended to 75% and at 42 days is. The DSMC must see something substantial in the gap of 28-42 days and we can’t us the data to capture the gap in time for the first 50% of the trial data at the new 42 day end point. UNLESS they continue the trial with the modification of 42 days so they could use that time for the whole data collection start to finish with 42 days as end point. So they recommended to continue the trial with that 42 day modification with a interim look again at 75% completion of the trial.

The thought was it may show in the placebo group another spike in mortality after the 28 days that wasn’t being included in the trial. Or better said, people on placebo were dying after the 28 days and not included in the trial results. This could bode well for stronger p value. It was not my prediction but makes total sense to me. If it’s true and more people were dying after 28 days then changing the end point to 42 days is good advice from a committee we paid to give us advise to help us succeed in the trial. Let’s hope a 75% interim look and at the new 42 day end point that our results are better and we achieve an EUA from this recommendation.