The upcoming EMA re-examination has the potential to become a battleground over the legitimacy of "established biomarkers." For instance, Anavex reported that its ABCLEAR3 subgroup* achieved an 84.7 percent reduction in decline in ADAS-Cog13 and met all other endpoints, including ADL, but made no claim about improved conventional biomarkers. Just yesterday, Novo Nordisk reported that its GLP-1 Phase 3 AD trial failed one the primary endpoint, CDR-SB, but did show conventional biomarker improvements.
Apparently conventional biomarkers in these two Phase 3 trials had no predictive value at all. I am very confident that Anavex will be arguing to the EMA that judging blarcamesine by the conventional A/T/N biomarkers misses the point of how the drug actually works.
* I am not suggesting that ABCLEAR3 will qualify as an approvable subgroup. Nonetheless, the results are the results.
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