Anavex Life Sciences Corp (AVXL)

[Hosai]

Just to remind, Lecanumab had their rejection over-turned to conditional approval after providing an ad hoc (not pre-specified) sub group analysis showing better safety in those without 2 copies of ApoE4 gene. Clearly CHMP can be open to ad hoc sub group data (sigma wt was pre-specified). See full doc here - https://www.ema.europa.eu/en/documents/medicine-qa/questions-answers-approval-marketing-authorisation-leqembi-lecanemab_en.pdf?fbclid=IwY2xjawN-_yRleHRuA2FlbQIxMABicmlkETFtTXJpeXZGQ205VVFJSDRWc3J0YwZhcHBfaWQQMjIyMDM5MTc4ODIwMDg5MgABHp2Wp7-ulwClyAPTMK3nMKKXZK552QEhNe8c2_kcUc8OBmPIljKRgKFUSVAL_aem_aXMBSHwipC766mUUmRzx2g

To also remind, Blarca beats Lecanumab on both ADAS COG and CDR-SB, way better safety and preserved brains instead of shrinking them:

Lecanumab ITT CDR-SB dosed vs placebo = 0.45
Blarca ITT CDR-SB dosed vs placebo = 0.483
Lecanumab sub group EMA approved: CDR-SB dosed vs placebo = 0.53
Blarca CDR-SB sigma WT sub-group dosed vs placebo = 0.601
Lecanumab ITT - ADAS COG dosed vs placebo = 1.44
Blarca ITT - ADAS COG dosed vs placebo = 2.027
Blarca sigma WT group ADAS COG dosed bs placebo = 2.317
Lecanumab sub group EMA approved ADAS COG = We are not told but it says of the sub-group "The results of other key measures indicated a similar effect to that seen in the CDR-SB score." Considering ADAS COG not mentioned I would imagine the sub-group not much better than Lecanumabs ITT score for ADAS COG.