Perhaps the FDA efficacy stop protocol does not an
Post# of 154105
(Total Views: 642)
Posted On: 08/03/2020 6:35:12 PM
Perhaps the FDA efficacy stop protocol does not anticipate a human trial for a potentially death-imminent disease, like in days? I could see that possibility.
The physicians in the DSMC know very well what happens if those placebo patients are not immediately dosed with leronlimab if those DSMC physicians observe the need for an efficacy stop. Hard to believe they just wouldn't take matters into their own hands.
But maybe the DSMC physicians will observe the FDA protocol.
Someone posted DSMC guidelines from the National Institute for Dental and Cranio Facial Reconstruction (NIDCR) but I don't think we can use those
The physicians in the DSMC know very well what happens if those placebo patients are not immediately dosed with leronlimab if those DSMC physicians observe the need for an efficacy stop. Hard to believe they just wouldn't take matters into their own hands.
But maybe the DSMC physicians will observe the FDA protocol.
Someone posted DSMC guidelines from the National Institute for Dental and Cranio Facial Reconstruction (NIDCR) but I don't think we can use those
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