Anavex Life Sciences Corp (AVXL)

[Investor2014]

Regarding P2b/3 AD dose and other predictions.

The Part A P2a trial used a crossover study with 30mg and 50mg.

Then for richness of data and analisys, 10mg and 20mg dose groups were added dividing patients into 4 dosing cohorts, which have now ended up concluding that the 50mg High cohort does best by far.

The Medium dose group of 30mg was conflated with the low dose groups of 10mg and 20mg in the 148 week data analysis (Low/Med).

All of this makes me predict that the dose arms in the P2b/3 trial will be 30mg and 50mg. It will show some difference in response to double verify the P2a findings, yet it will not rob the low dose arm patients of clinically meaningful response.

Being in the placebo arm sucks! But IMO that situation won't be allowed to persist for long Down Under. We will get AU conditional approval say half way through or at whatever point the seamless transition from P2b to P3 is planned.

At that point all patients Down Under will be moved to a 50mg dose for the remainder of the trial and beyond. At the same time a North American cohort will be added on 50mg for the confirmatory P3 stage.