Anavex Life Sciences Corp (AVXL)

[abew4me]

Pros and cons for Anavex investors.

I'm trying to keep an open mind as to what could prevent A2-73 (Blarcasemine) from getting approved by the EMA or the FDA. I've heard most of the positives...but it's just as important to know what are the negatives. Below are the only three points (pros and cons) that come to mind...

Con = The 48-week P2b/3 study (at n=509 patients) is too small and didn't allow enough time to evaluate the efficacy...at least when you compare it to the typical AD studies that normally had n=1,000+ patients and lasted over two years.

Pro = The larger AD studies needed 1,000s of patients in their studies so they could find a sub-group that would respond positively to their drug. Once they found a sub-group, it would probably equal the same number of responsive patients in our "small" P2b/3 study. The measurement of efficacy over a longer period of time should be alleviated with the results from the 96-week OLE study. Taken together, our NDA will have almost three years of data.

Con = The P2b/3 study doesn't include enough ethnic groups...at least for the FDA - which usually requires a good representation of black and hispanic groups to match the U.S. population as a whole.

Pro = Although it is true that our P2b/3 study recruited most of their patients in Australia, they later expanded the recruiting efforts to Spain and other European countries. (If anyone can find the exact breakdown of patients in each country, I would greatly appreciate it!)

Con = The Anavex team does not know what the results are from the (96-week) OLE that will conclude on July 31st. If it doesn't maintain the positive results that were achieved from the 48-week P2b/3 study, it could diminish our NDA.

Pro = TBA

If you have any other concerns (cons) please add them to this list.

Thanks.

abe