(Total Views: 502)
Posted On: 10/20/2020 1:47:00 AM
Post# of 145875
If you look at the fda description of the responsibilities of the DSMC, you will see that the committee can make recommendations on numbers of patients, dosages, criteria for patients and other changes based on interim reviews. I believe that the oblique reference to potential regulatory paths forward may be a product of the impact of recommendations of the DSMC. However at this point many here are wrestling with the terminology of the PR.
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