I think that 28-60 day window sailed when CYDY mad
Post# of 155006
(Total Views: 739)
Posted On: 03/05/2021 11:52:44 PM
Re: Goosebumps #81031
I think that 28-60 day window sailed when CYDY made the (bad) decision to not take the DSMC's recommendation. The data integrity is such a controlled aspect of the trial. I don't think one can just pull data like that and throw it in with the "clean" data set. Plus the PR never mentions extending the window, only that they need a larger sampling and that they are already on it. I agree that we show encouraging numbers for mortality for critical but the reality is the population (62) is just too small for an FDA that traditionally requires an adequately powered trial.
My prediction is that the current results are not adequate for an EUA but they do show some encouragement if the sample size is increased thus CYDY will work very hard to enroll an agreed upon (with the FDA) number of critical patients so that it has enough power to satisfy the FDA's conservative handling of drug approvals.
My big question is why didn't the DSMC see this coming and make the proper recommendation at 50% look, or did they and CYDY ignored it, thinking like many on this forum that the 42 day look was like icing to get stat significance faster.
My prediction is that the current results are not adequate for an EUA but they do show some encouragement if the sample size is increased thus CYDY will work very hard to enroll an agreed upon (with the FDA) number of critical patients so that it has enough power to satisfy the FDA's conservative handling of drug approvals.
My big question is why didn't the DSMC see this coming and make the proper recommendation at 50% look, or did they and CYDY ignored it, thinking like many on this forum that the 42 day look was like icing to get stat significance faster.
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