Anavex Life Sciences Corp (AVXL)

[Hosai]

I believe EMA at-least would have already seen the TEAEs etc.
Lower n is less ideal but it makes it harder to show a low p value so does in a sense show consistent efficacy strength in that regard.
As I said before main issue was the 50mg group TEAE dropout.
35.7% TEAE dropout for 50mg, 24% dropout for 30mg (30.7% pooled) and 7.1% placebo.
From what I can tell when you add the non TEAE dropout (extrapolating from final ADAS COG scores we are given) it mean completion for 50mg group was only around 49.4%. For 30mg was 64.7% (57% pooled) and placebo completion was 72.6%.

However again to frame things against Donnanemab who are FDA approved, they had 21.2% dropout due to AE versus 8% placebo and after non-ae dropouts added they had at end of trial around 67.8% dosed group completion of primary endpoint versus 74.5% placebo.

Therefore the 30mg group isn't far off Donenamab completion % here. 30mg group met it's endpoints with p values around 0.026 and 0.02. The very low p value for grey matter finding 3.3 in 1,000 chance of being due to chance with fairly decent effect size is clearly impressive too and with higher 50mg dropout the larger ratio of this pooled data must be from the 30mg cohort.
Drug hasn't caused any deaths related to drug or ARIAs and the dizziness didn't seem to result in falls with falls higher % in placebo group. Safety data can also be added from Parkinsons and RETT data as-well as soon OLE. When you had all that up a decent sized amount of people have been on Blarcamesine.
As has also been mentioned this was a trial with around 10% exclusion vs 70/80% from Donnenmab and Lecanumab.
Could see the EMA approving at 30mg with confirmatory study being required for higher dose or evidence that nighttime dosing/slower titration was making a difference to tolerability.