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Posted On: 02/24/2021 1:19:45 PM
Post# of 148900
This was my concern as well. In light of what we know about increasing quality of SOC, the DSMC request for 42 day mortality data, RLFTF now looking at 60 days, it seems certain to me that we have way under-estimated the number of deaths that were beyond day 28. IMO, I think the total deaths within 28d is somehwere in the 60's rather than 87. So if the 28d mortality is let's say 67 instead of 87, will there be enough events to have the power to show stat significance even though LL may show a large reduction in mortality.
I think this is the current problem with the Primary Endpoint, not enough deaths within 28d and now CYDY needs time to make the case for Secondary Endpoints and these are the discussions being conducted with the FDA & other authorities. I truly hope 42d data was being collected despite the decision to forgo 75% interim as it will provide the number of deaths needed to show stat significance.
I think this is the current problem with the Primary Endpoint, not enough deaths within 28d and now CYDY needs time to make the case for Secondary Endpoints and these are the discussions being conducted with the FDA & other authorities. I truly hope 42d data was being collected despite the decision to forgo 75% interim as it will provide the number of deaths needed to show stat significance.
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