So, from past experience, we know that the PR anno
Post# of 148110
Th DSMB has 3 basic things to consider: futility, harm, and overwhelming positive effect. the CD12 trial is ongoing unless it is recommended otherwise for any of those 3 options. We know Leronlimab is safe and effective so there is no stopping the trial from futility or harm.
If there is overwhelming positive effect, correct me if I'm wrong, but that means the sponsor would need to go to the FDA and ask to end the trial and approve based on that, possibly ask for EUA or ask to have the trial accelerated or changed to save time. It sounds like the FDA is reviewing the un-blinded data, so that would tell me that what the DSMB saw was enough to present to the FDA or the FDA is watching this closely and wanted to see the data as it is now just for there own reasons.
I can only think the trial data must be good, or the trial needs adjustment for some reason. It could be they want to modify the criterial to speed up enrollment, it could be they want to allow the placebo arm to get Leronlimab after showing no improvement because it is a deadly situation.
I'm not worried other than if this drags on for a few more months as the trial completes.