Anavex Life Sciences Corp (AVXL)

[rx7171]

Can I just step back a bit and discuss the point of a confirmatory trial.

OK I get that at some time in the past it became the unofficial standard to have two independent trials to avoid accidental or intentional errors in a single trial leading to approval of a dangerous or ineffective drug.

In our case we had 52 trial sites in several countries all of which have an excellent reputation for running trials.
The data was very positive with excellent P values, except for ADL which we know from OL data to no longer be an issue.

I fail to see what another trial could possibly show beyond a few percentage points difference from the data already in hand yet still passing with flying colors.
The original data is miles away from being on the edge of failure.
Was the original trial run as a giant conspiracy by 52 independent sites to create bogus data?

Ok conditional approval with data gathered while marketed but I see another trial as unnecessary and a small cloud over a spectacularly effective drug serving an enormous unmet need.

In addition another trial will take company resources from trials in other indications delayed for years.