Sorry, I don't know specifically what the DSMB was
Post# of 154867
(Total Views: 569)
Posted On: 08/05/2020 1:19:24 PM
Re: reallypeople? #47247
Sorry, I don't know specifically what the DSMB was asked to do on Monday, and don't have anything to add to what everyone else here has already said. For sure they were asked to review adverse events, and if the addition of leronlimab to standard of care was harmful, they would have stopped the study.
I am guessing they reviewed the number of deaths and other SAEs in each arm, and the difference wasn't large enough (according to what criteria?) to recommend doing anything besides continuing the study. I thought it possible they could have seen far fewer deaths in the leronlimab arm and stopped the study, but that didn't happen. It's possible they weren't asked to make that recommendation one way or the other at this point. The great majority of DSMB meetings concludes with "continue the study as planned." That's what we got. Now we wait for interim data analysis in ~8 weeks, which will have statistical guidelines for stopping for efficacy and futility, and for continuing on to full enrollment of 390.
If mild to moderate data show significant clinical benefit, these safety data in severe to critical Covid will help support approval (at least for mild to moderate Covid). Hopefully we get that good data, and FDA will want to see everything we have for LL in Covid (all EIND, CD10, and CD12 data up to that point) to decide on EUA. We should find out next week some time.
I am guessing they reviewed the number of deaths and other SAEs in each arm, and the difference wasn't large enough (according to what criteria?) to recommend doing anything besides continuing the study. I thought it possible they could have seen far fewer deaths in the leronlimab arm and stopped the study, but that didn't happen. It's possible they weren't asked to make that recommendation one way or the other at this point. The great majority of DSMB meetings concludes with "continue the study as planned." That's what we got. Now we wait for interim data analysis in ~8 weeks, which will have statistical guidelines for stopping for efficacy and futility, and for continuing on to full enrollment of 390.
If mild to moderate data show significant clinical benefit, these safety data in severe to critical Covid will help support approval (at least for mild to moderate Covid). Hopefully we get that good data, and FDA will want to see everything we have for LL in Covid (all EIND, CD10, and CD12 data up to that point) to decide on EUA. We should find out next week some time.
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