It turns out there is a process that drugs have to go through to approved and licensed before they can go on the market.
One of the big steps is filing a New Drug Application (NDA) something that Anavex hasn't done yet. So if you want to place balme for 2073 not yet being on the market, blame Anavex for not filing an NDA.
Or you might consider that the process has steps that are required and Anavex is working through the process.
Anavex has not completed any large trial for any indication - the AD trial of 509 patients is the biggest one - shows strong positive results and then complain