Anavex Life Sciences Corp (AVXL)

[Hosai]

We already had the ADL charts for 48 weeks at AAIC and it was indeed a fall for both - https://www.anavex.com/_files/ugd/79bcf7_0272a8a1d5c54d5daff717f8e4450529.pdf

I don't think the the fda guidance was implying it would be totally flat though it was understood there is still some functional decline, however ADL scale isn't sensitive enough to see any changes from a drug vs placebo was in part an argument but I admit you have a slight point that large falls in the scale may undermine this argument.

FDA had clearly softened on ADL either way, see stage 3 section in final page of the draft guidance - https://www.fda.gov/media/110903/download

It is a slightly odd that CGI-I is so stat sig at the 48 weeks (I believe pooled p value was around 0.003) whereas ADL nowhere near.

If it was case that ADL endpoint had to be held up a clear co-primary fail (rather than viewed under the new guidance), Dr Jin can make the argument he made in Sept 23 which was the co-primary end point and secondary were both under 0.025 p value making the trial according to him a success.

There is also obv the argument now that it appears the ADL group did eventually beat the original placebo group in the long term.