Replies to post #475824 on Anavex Life Sciences Corp (AVXL)

[Hosai]

EMA pretty much approved Lecanumab on a post-hoc (obv only for a sub-set of patients).

[boi568]

I agree that we can't rely upon our amateur analysts as we would for professionals.

As for your placebo point, the proper comparison, as was done in the case of the S1R WT and its mutation, is to compare against comparable populations in the placebo group and not the combined set placebo you are referencing.

[Steady_T]

If you are going to compare the remaining population of the ITT with the COL24A1 subtracted to the placebo group, you need to subtract the COL24A1 from the placebo group to get a fair comparison.

[BAR123]

I think that you can count on a confirmatory trial with the EMA. That is not so bad as they have 5 years to get it completed I believe and they will be selling the drug the entire time. https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-investigation-subgroups-confirmatory-clinical-trials_en.pdf