I was wondering the same hopefully the presentation will explain further. Still is nice to be arguing between a 2.26 in a 100 chance of being due to chance versus and 8 in 1,000 chance of being due to chance. The latter is is clearly in the ITT population too which as investor pointed out over the last 3 months is the most the key analysis.
It could be that the p value for 0.008 in ADAS COG ITT was a pooled p value of 30mg and 50mg wheras the 0.026 p value from Sept 23 was just for either 30mg or 50mg considering it's roughly similar to the p values given for 30mg and 50mg each on their own in the AAIC slides. Obv the pooled p value was always going to be lower that the indivdual p values due to higher (n).
The standout info from the CTAD 2024 presentation is that, per March 2024 FDA guidance and EMA guidelines, a sole cognitive measure can serve as a primary endpoint for early AD trials (slide 13).
Since there’s no mention of statistically significant results for the S1WT subgroup ADCS-ADL or CGI-I endpoints, it seems these weren’t met. So, approval would depend on the new FDA/EMA criteria, not the original SAP.
The minimal separation in Cog scores until/only week 48 makes the OLE results crucial to confirm if this efficacy holds.
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