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Tuesday, June 06, 2023 4:57:22 PM
Well the proposal would likely have been rejected by the FDA since AUC is nonsensical with just baseline and two sample points and hence the AVATAR trial was non pivotal P3 fail with interesting P2 signals.
In the latest Excellence PR, AUC is not mentioned hopefully because Anavex and Missling have been educated by the FDA to use EOS mean.
So what happens if the baseline to EOS mean is not clearly stat sig, whereas AUC might be?
I think we need to hope the EXCELLENCE coin flip comes up with a baseline to EOS success.
So far Missling have declined to release the AVATER eos mean result, why given the latest FDA guidance Anavex have received?
In the latest Excellence PR, AUC is not mentioned hopefully because Anavex and Missling have been educated by the FDA to use EOS mean.
So what happens if the baseline to EOS mean is not clearly stat sig, whereas AUC might be?
I think we need to hope the EXCELLENCE coin flip comes up with a baseline to EOS success.
So far Missling have declined to release the AVATER eos mean result, why given the latest FDA guidance Anavex have received?
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