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Posted On: 10/23/2020 12:52:04 PM
Post# of 148903
Ohm wrote: They [the FDA] can't do anything without data.
But if the FDA was working with the DSMC before the DSMC recommendations, surely they must have seen data -- or what else would they be talking about/working on?
I would have assumed the FDA and DSMC together came up with the idea of doing a 3/4 interim analysis.
Or if they saw no data, at least they would know that Leron was close to achieving statistical significance at the halfway point.... without knowing the actual numbers.
But if the FDA was working with the DSMC before the DSMC recommendations, surely they must have seen data -- or what else would they be talking about/working on?
I would have assumed the FDA and DSMC together came up with the idea of doing a 3/4 interim analysis.
Or if they saw no data, at least they would know that Leron was close to achieving statistical significance at the halfway point.... without knowing the actual numbers.
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