Anavex Life Sciences Corp (AVXL)

[jimmy667]

The PDUFA is possibly to blame for the mess-up in drug development. For which one can as usual and should blame Congress and the lobbyists for BP. As an upstream tax on research and development is stiffles it. The FDA should not be funded by a development tax but rather downstream tax on all drugs approved and marketed or general revenue as in the DoD.
Pharma Drug User Fee Act favors BP and easy to approve indications or label modifications to existing drugs and disfavors hard to crack indications and smaller market drug indications and of course as intended by BP lobbyists smaller upstart Biotech. The only way rare indications are pursued is by the Orphan designations. It is a complex issue but the way the FDA is currently funded is inconsistent with precision medics as drug are targeted to select individual subsets of an indication as in oncology currently so become a an economic issue.