Anavex Life Sciences Corp (AVXL)

[DrJan]

After 48 weeks ADAS-Cog13 decreased with about 4.6 Vs 7.3 units on placebo. So, on treatment patients are still suffering and the disease progresses, but somewhat less than on placebo. Results may even seem better than on competitor drugs, but that’s unproven, as this is no H2H trial and patient groups are different. So, probably a small real effect, but via an unproven mechanism, in one small trial, not significant in all parameters, without comparison with drugs already on the market.
It may even be enough to get regulatory approval, the biggest hurdle now, but the delays in filing and peer-reviewed paper already shows that this is not a slam dunk. Very rich Big Pharma will be pushing back, influencing the market with any means they have.
You cannot target regulators, but indirectly you can influence them by building support from the market. It's naive to think it's all about science and data. At the moment scientific organizations and KOL networks are hardly aware of Anavex. Except from a seldom article in an Australian newspaper, there Is nothing and company presentations are very scarce and poorly performed.
People with experience in launching a drug could tell him, but there is nobody.