Well, if you're going to insist on being That Guy,
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Posted On: 12/16/2020 12:31:39 AM
Re: ClosetInvestor #68336
Well, if you're going to insist on being That Guy, I would totally ignore the DSMC because they have nothing to do with the study, whoever they are.
The DSM*B*, on the other hand, was responsible for observing the study, making sure safety was met and there were signs of efficacy. They made a recommendation to measure mortality past 28 days FOR INTERIM ANALYSIS at 75% ENROLLMENT to TRY TO ESTABLISH HIGHER SIGNIFICANCE IN A SMALLER COHORT.
They NEVER RECOMMENDED adding that TO THE FULL STUDY.
So I would hope CytoDyn does whatever they seem fit, and ignore you and your DSMC... They sound suspect.
The DSM*B*, on the other hand, was responsible for observing the study, making sure safety was met and there were signs of efficacy. They made a recommendation to measure mortality past 28 days FOR INTERIM ANALYSIS at 75% ENROLLMENT to TRY TO ESTABLISH HIGHER SIGNIFICANCE IN A SMALLER COHORT.
They NEVER RECOMMENDED adding that TO THE FULL STUDY.
So I would hope CytoDyn does whatever they seem fit, and ignore you and your DSMC... They sound suspect.
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