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Posted On: 12/15/2020 10:31:24 AM
Post# of 154115
Re: Goosebumps #68214
“Trial complete? Is it today? Would be nice to start the 28 day clock. Who knows the time needed for analysis for the data? 28 days + ? for analysis? Is it a week or more time needed?”
What are your thoughts on the DSMC’s recommendation to analyze the data at 42 days and whether or not CYDY should analyze 28 day, 42 day, or both after full enrollment?
Yes, the DSMCs 42 day recommendation was for the 75% interim analysis, but they made the recommendation for a reason (a reason we don’t know) in order to best guide the trial. Now that the 75% interim analysis has been canceled, we won’t know why the DSMC wanted to see data at 42 days and what their recommendation at 75% would’ve been.
What are your thoughts on the DSMC’s recommendation to analyze the data at 42 days and whether or not CYDY should analyze 28 day, 42 day, or both after full enrollment?
Yes, the DSMCs 42 day recommendation was for the 75% interim analysis, but they made the recommendation for a reason (a reason we don’t know) in order to best guide the trial. Now that the 75% interim analysis has been canceled, we won’t know why the DSMC wanted to see data at 42 days and what their recommendation at 75% would’ve been.
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