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Posted On: 03/04/2023 7:32:48 PM
Post# of 148870
According to the article at link below, the mortality rate was 20.2% (19 of 94) for sabizabulin versus 45.1% (23 of 51) for placebo (SOC). 45% for SOC is high.
The following is from the FDA Briefing Document which is linked in the article:
The FDA Review team acknowledges that Study 902 met its prespecified primary endpoint of all-cause mortality at Day 60. We also note that the VERU-111 program is quite small in size compared to other therapeutic programs for patients hospitalized with COVID-19. As detailed in the briefing document, our review has identified a number of uncertainties with the data, which we raise in the context of this small trial in critically ill patients. These include:
•High placebo group mortality rate
•Potential for unblinding events with enteral tube administration
•Baseline imbalances in standard of care therapies
•Differences in hospitalization duration prior to trial enrollment
•Uncertain effects of goals of care decisions on all-cause mortality
http://onbiostatistics.blogspot.com/2023/03/
The following is from the FDA Briefing Document which is linked in the article:
The FDA Review team acknowledges that Study 902 met its prespecified primary endpoint of all-cause mortality at Day 60. We also note that the VERU-111 program is quite small in size compared to other therapeutic programs for patients hospitalized with COVID-19. As detailed in the briefing document, our review has identified a number of uncertainties with the data, which we raise in the context of this small trial in critically ill patients. These include:
•High placebo group mortality rate
•Potential for unblinding events with enteral tube administration
•Baseline imbalances in standard of care therapies
•Differences in hospitalization duration prior to trial enrollment
•Uncertain effects of goals of care decisions on all-cause mortality
http://onbiostatistics.blogspot.com/2023/03/
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