Anavex Life Sciences Corp (AVXL)

[Doc328]

I don't think the Rett trial results will have any significant bearing on AD. Efficacy data from Rett won't have to be part of any application and safety data will be added without much effort.

I disagree with most on this board as to the significance of the recent Anavex PR's regarding applying for the Centralised Procedure (CP) request and then receiving CHMP/EMA eligibility to submit an MAA under the CP. This is a procedural event that streamlines an eventual application submission but does not offer an opinion. The short review would not have looked at much detail of the study.

As an example: To get a concealed carry in my state you need to first take a course from a licensed instructor and pass a simple test and even simpler 30 round target. After this relatively painless 6 hour process they will give you a certificate valid for a certain time (in this example this is analogous to what Anavex has done). Last year, my wife and I both took a concealed carry class and passed. We then took divergent paths. I went ahead to the sheriff's website and completed the application (in this example the MAA) and paid my fee. If I had not done the initial procedural element of the class and passing a test, I would not have been allowed to apply (can't do CP without the initial CHMP/EMA waiver) After the background check I received my CC license. My wife, despite taking the CC class and receiving the certificate (analogous to the CP waiver), opted not to go ahead and do the actual CC application (the MAA). Many other examples like passing the screener on Indeeed.com in order to be allowed to apply for a job but then being told in a screening interview (the rapporteurs) that you are not a good fit before the actual interview (MAA). Obviously the MAA process is more complex. But the point is that receiving permission to apply is not the application. Theoretically, Anavex could apply in June (by my calculations). Anavex has passed a minimum checklist to be given access to the EMA personnel - preclinical trials, GMP documents, human data. Now the EMA will give the emails and phone numbers of the rapporteurs which will open a line of communications. I do not think Anavex will apply in June, or even at all without an additional trial.