AI
Thursday, October 31, 2024 2:53:20 PM
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.
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.
