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Monday, February 13, 2023 11:11:19 AM
Using AUC with just two data points vs. baseline to EOT is also consistent with the flip of a binary switch and tempting if EOT wasn't looking so good.
I doubt very much that the FDA commented directly on the AVATAR trial, which had no U.S. trial sites.
And yes, regardless the AVATAR trial was too small to stand on its own two legs. Just like the prior adult trial that was run in the U.S. and was not reported using AUC despite being within the jurisdiction of the FDA.
The hope is that when EXCELLENCE is analysed, also together with the data from the two adults trials, the signal becomes stronger. Still all 3 trials are short and with EXCELLENCE being 12 weeks not clear how many data time sample points there are.
Maybe the FDA asked for it because of the small sample size.
I doubt very much that the FDA commented directly on the AVATAR trial, which had no U.S. trial sites.
And yes, regardless the AVATAR trial was too small to stand on its own two legs. Just like the prior adult trial that was run in the U.S. and was not reported using AUC despite being within the jurisdiction of the FDA.
The hope is that when EXCELLENCE is analysed, also together with the data from the two adults trials, the signal becomes stronger. Still all 3 trials are short and with EXCELLENCE being 12 weeks not clear how many data time sample points there are.
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