After the back and forth Missling had with the BGIT analyst on AUC and endpoint, I can’t see a different endpoint measure is used for EXCELLENCE but the standard endpoint measure. The bar is set by Acadia and confirmed by FDA!
I am, however, very impressed or puzzled by Anavex’s ability to manufacture the trial success without knowing the trial efficacy data. The trials either have stellar efficacy (e.g. US RETT) or just enough efficacy to get by with changed endpoint measures (e.g. international Adult RETT, AD p2b/3). How did Anavex figure out efficacy and what to modify without knowing the efficacy data? Is there another bio having the same track record? Is it an indication the drug is good or pure luck?
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