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Posted On: 07/22/2020 2:27:02 PM
Post# of 154119
Quote:The DSMC investigation slated for next week is not an interim look.
I thought he said they have 100 patients in the CD-12 who have completed the trial (28 days+) and they would be taking an interim look at primary endpoints for this cohort
It is a safety look only -- and we only have 100 who have completed the entire 28 duration of the trial.
The DSMC can decide to:
1. Terminate due to futility
2. Recommend proceeding to interim 50% (195)
3. Terminate due to overwhelming benefit
The interim look can only happen at 50% (195).
Last Saturday Dr.NP said there were 152 patients enrolled in the S/C.
Today, four days later, there are only 153 patients enrolled.
Therefore, we need 42 more enrolls.
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