Anavex Life Sciences Corp (AVXL)

[Investor2014]

I'll defer the AD stage and ADL outcome measure technicalities to Doc.

My simple take is that if/once we see an MAA filed and validated by CHPM, then pass clock-stop one of the EMA process a new situation is established, where A2-73 will likely be approved in AD without ADL being a crucial co-primary endpoint concern and with an acceptance of the overall effectiveness of A2-73 on biomarkers, safety and efficacy in some yet to be identified/revealed subgroup of patients.

All this may be about a year away and is a really good test for Anavex as an investment grade company and its future. I think people can and will make up there own mind as to the prospects if an EMA approval is not forthcoming.

In this new situation with the new FDA guidance it would make sense then for Anavex to file a well prepared NDA around the time of the EMA clock-stop one pass, which the FDA would then in turn likely approve. I don't expect to see parallel filings, the costs of those and the risk of multiple rejections being a possibility.

I wouldn't expect any wonderful developments or peer reviewed paper to accelerate approval hopes outside clear progress with EMA.