Anavex Life Sciences Corp (AVXL)

[Investor2014]

The majority of patients so far fall outside what seems the therapeutic window above 4ng/ml of A2-73 in plasma concentration.

The data also show outliers with opposite response to plasma concentration, one doing very well on very low concentration and a few doing poorly on high concentration.

From slide 15 of the October PK/PD presentation we see an overall clear R-squared trend comparing dosing period concentrations, but which also exhibit a few significant outliers especially and critically in the longitudinal comparison of time periods on the right.

Analysis should ideally explain:

1) Why the majority of patients are in sub 4 ng/ml plasma quadrant
2) The outliers
3) How to get more patients safely above 4 ng/ml plasma concentration

But we will likely not get all the explanations from the very small n P2a study.

If we get enough hints to excluded the sub 4ng/ml patients, then chances of success in the P2/3 study will be greatly enhanced. THIS IS THE TASK and probably it is complex and confounding, but a nut the company really would like to crack.

A bonus task will be figuring out a way to safely administer a tolerable dose bringing concentration above 4ng/ml in more patients.

There are some theories here e.g. DPZ naive, the company now focusing only on mild AD patients, something to do with the gut and DNA and what have you.

IMO most likely these tasks are the reason things are dragging out a bit, rather than the idea that the company is deliberately holding back waiting for some government agency to get all it's ducklings in row.

As to when it began to dawn on Missling that he wasn't ready to launch the trials and whether the delay has been 'helpful' for raising more LPC cash, we shall likely never be told. I am still of the view that with the answers giving confidence in the P2/3 study all of this will be forgotten and forgiven.



Happy New Year!