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Posted On: 10/16/2020 10:59:43 AM
Post# of 149265
So, from past experience, we know that the PR announcing a CC is nothing to read too closely. In the past the announcement includes topics for the CC and the CC sometimes does not covert hose topics and sometimes covers more topics. The pre-send questions is just a better way of filtering out un-important questions etc.. In other words, I am not reading too much into what every word in the C announcement means. The only 2 reasons a publicly traded company has a CC is because they have to announce something or they want to update on progress/status. Given that there has not been a PR with material developments, makes me think this CC is and update on status.
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.
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.
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