Anavex Life Sciences Corp (AVXL)

[nidan7500]

Hey FDA, if you don’t want to work with us, we can get this done with or without you.

Nice message with all these international sites set up.

We can expect that when there is THIS MUCH money/control/politics/prestige...) involved that there is literally NO LIMIT on what might be done to prevent AVXL from crossing the goal line.

Dr.M. knows/understand that point . He has basically taken the leverage away from the established system by emphasizing EU/AUS/Japanese/other trial bases. The science is one thing but if the cards are being stacked against you, you better have a Plan B.

The US CNS disease science has been sooo far off for sooo long nothing in place should be considered to be a valuable ref.. The (FDA Gold Standard) system is broken and ineffective. It is time to redo some methods and practices. That is a part of what we are seeing. We have the option to revert to FDA systems if we see that path open. THE recent conference FDA-PDD head fake w/breaking news headline was a clue, IMO.

Time is running out on the decades of poorly planned FDA trials/regulatory games. Soon we are going to play hard ball. IMO, we got all the ammo we need. Something wrong w/this regulatory historical results/control culture. It is obvious now that 30+ years w/o any real CNS science win or direction is about to look to be systemically incompetent.

AVXL has the existing system in a corner. They must work w/the AVXL plan WW. We have the results, there is no way out. IMO.