the major feature of the remdesivir trial that pus

the major feature of the remdesivir trial that pushes towards approval is the large number of patients in the trial.

it was 1500 or 3000 or something like that.

wilth an order of magnitude more patients than CD12, the statistical math is more favorable for a positive p value outcome. Thats just how the statistical math works.

the challenge for cydy is that even with excellent results, lets say 11 deaths in placebo and 11 deaths in leronlimab, the p value may not be sufficient.

Equal deaths in the placebo and leronlimab is a massive success. Its a reduction of mortality by 50% because leronlimab arm has twice as many pateints as placebo arm.

but if i run the woldram alpha two binomial distribution test at the below URL, the p value is not good enough with 11 deaths in each of the LL and placebo arms.

Is this formula the correct math for this case? I don't know. It might be.

Maybe someon knows the correct statistical math formula for p value for the CD12 trial.

The p value gets even more difficult to hit as the standard of care improves survival.

Maybe the FDA will approve on reduced mortality even if the p value of 0.05 is not met? I wonder if that has ever happened before.

https://www.wolframalpha.com/input/?i=two+bin...2%2F130%22