Replies to post #136709 on Anavex Life Sciences Corp (AVXL)

[Investor2014]

Below does not read to me as waiting for the FDA.

I have said many times the company IMO is spending the time it takes to ensure their inclusion/exclusion criteria, based upon the data analysis, gives the best chances of P2/3 success.

IMO, making the company's future plans dependent on a government agency's potential future announcements seems a bad plan.

If and when new FDA CNS guidance beneficial for A2-73 approval are released in advance of AD trial readout, would there be any reason for it not to apply provided Anavex have chosen and agreed with the FDA applicable end-points? I think not!

I don't know of trial designs that Anavex might want to opt for that are not possible under current guidance. Does anyone else?

If readout is before any new useful CNS guidance and the data is convincing, perhaps any new guidance is not really essential for approval.

I'd rather wait the extra time for better risk/reward ratio, than rush into a trial to satisfy the short term anxiety of some on this MB.

Jason Helfstein

Hi. Congrats on the progress and thanks for taking my questions. I'm curious about the open-label extension trial you have running in Alzheimer's, can you remind us when we might see data from that study and do you need that data before you meet with the FDA to discuss your next Alzheimer’s study.

Christopher Missling

The answer to both questions is that the data will be - the trial will be finished in end of 2018. It will be a full 104 weeks, plus a 57 week from the previous 002 study. So, total of three-year cumulated daily dosing of ANAVEX 2-73. The answer to the second question is, we do not need that data or we do not have to wait for the end of that extension study to initiate a larger Alzheimer’s study. As a matter of fact, it will start before that trial will be finishing.

Jason Helfstein

Okay, thank you. And then, have you disclosed what types of patience you will be studying in your next Alzheimer’s trial, will there be mild-to-moderate and how many patients you are planning to enroll in your next trial?

Christopher Missling

Yes. We did disclose at the CTAD conference that the inclusion will be patient with mild disease. We've found a correlation of stronger signal with the patients who had a milder disease stage than more severe stage. So, we will focus on mild patient. The final calculation of the patient will depend, as you just heard, from the integration of the genomic data and that would lead them to the final number of patients in the Phase 2/3 study.