Anavex Life Sciences Corp (AVXL)

[nidan7500]

We see these issues around here all the time

It would be great if the FDA was wired in and helping w/precision science based trails but obviously they are not. My guess is that RS hold has more to do w/internal FDA old school vs Precision Medicine than it does with AVXL. Between new politics w/Dr G. internal to the FDA politics/power base and how things get done. The old school controls and power bases are being taken out by systems and AI tools. This will result in a kind of process vacuum which AVXL must have been caught in through no fault of AVXL. I am guessing but it makes sense. The old school processes for decision making and endless drafting and controls of guidelines will last a lifetime, which we do not have. It is kind of a long story but that is what we are seeing, combined w/very real established payment routes to DC politicians looking out for their interests.

We are out on a limb but if AAIC process results show test results/links to DNA/Biome markers which then link to trial results then we are in a new ballgame. Far less dependency on FDA guidelines and driven by patient hard data/treatment results. Dr.M. is on the point but we waited and played their games until it almost killed us. Suddenly the FDA just became less relevant.

My non science view of what is going on. The data will obviate the need for endless discussion/influence and rethinking/stop/second guess being in control FDA politics. It will get better over time but the old ways will die hard.

We will know it's done when we see it, but instinctively we can see what is going on around FDA control changes.