Anavex Life Sciences Corp (AVXL)

[nidan7500]

Talon, as a pilot you understand pilot In Control/Command (PIC). It looks to me like no one is flying this airplane.

The process of drug development from research to market is a process of low risk and liability avoidance. The horror story of Thalidomide lurks in the minds of public health officials and is the body of possibility of the product liability lawyers. So the process pits the adverse risk of the few against the certain death of millions. Big Pharma has been playing this game for years and their corporate thought process and their research mechanisms have been developed accordingly. Money, size, and minimal risk are the drivers of their drug development methods. They leave it to the small bio's to take the risk and buyout those who are successful, stepping over those who have failed

If we were to define the problem as..."We have a CNS disease (pick one) called AD which is killing our millions of our citizens and it is forecast to kill many millions more. (WHAT THE F ARE YOU DOING ABOUT IT?)???

CNS diseases (AD) now costs us a massive amount of money, there is no known effective treatment. After 40+ years of using our trial and error/statistically driven/lowest risk approach we get a 99.6% fail rate, assuming partial credit to something (dz) we all agree des not work. That is the best we can deliver. In the meantime we have the best brains in the universe working on a risk averse, hyper expensive ass covering model, but we have no time lines on when that will be ready"...That is about what I see as our "trail of tears" FDA-BP process model.

How about ( and I hate big central government control) we use business model which requires the FDA (or separate functional equivalent) to set up a process which funds based on merit for the selection of the best science. (figure out what that means) then set dates. Scale the deliverables and make the knowledge/data/tools developed public domain. Make it a kind of AD " Manhaten Project" like developing a weapon system. Get friggen real or go home.

As it is we rely on people like Dr M to somehow develop a product/solution and if he survives that the FDA gets it's array of experts to do pre flight inspections (yeah/nay)...then we put it in a hanger b/c it might not fly or it has a leak...and there is no way to actually test it. In the meantime pts are dying and the war is lost.

The first step in solving a problem is recognizing that one exists.

I suggest...Find a way to fund and evaluate promising technology (like A2-73). Find a way to get trials done on a priority basis by funding/and supporting trials. At least recognize the current process for development and evaluation of important new medical technology is broken, it has failed. De-conflict the science and funding. AVXL is being asked to develop the A2-73 AD solution and to then convince the FDA it is effective. That model is backwards, IMO.