Anavex Life Sciences Corp (AVXL)

[Investor2014]

Other key points:

1) CHMP apparently has not yet considered the replacement of the co-primary endpoint ADL with the secondary CDR-SB using the multiplicity rule requiring P < 0.025. Only the to protocol ABCLEAR1 wt. SIGMAR1 subgroup per protocol, which helped to establish MoA only.

2) Anavex is planning a confirmatory P3 trial in support of a CMA and likely also to satisfy FDA accelerated approval. The one Anavex should have initiated 3 years ago.

3) outcome of the CHMP reexamination is at least 6 months away. Anavex is still to submit the reexamination package. I think we should also couple that to point 2, insuring that trial is registered/initiated before the reexamination outcome.