Anavex Life Sciences Corp (AVXL)

[nidan7500]

TALON-What that means for us backing Anavex's drugs is that we may be unlikely to see our drugs as "knockout" solutions but rather as very effective targeted weapon

Agree with your point as well made on what I call precision weapons vs carpet bombing w/all the related collateral effects.

Additionally, I think we are in the middle of a process (FDA) "Transformational change" (Hacker QP March 18) "...the marked change in the nature or function of organizational systems creating discontinuous, step function improvement in sought after results area". "The transformation process entails an inflection point where the new system begins to move forward...".

Long story made short ...IMO the FDA is in the middle of a transformational change of processes (note : all work is done by process in the FDA , which is obvious when you study their docs/structure/etc.) I also see the FDA as being in the middle of a "Cultural change" and guess what, we are in it with them whether we like it or not. Evidence we have is the apparent recycling of IND apps and which many would recognize as the .."Fetching Rocks exercise" which most have familiar with. It occurs when new information brought to the process then begets new questions which no one would have thought relevant before. This practice is based on the principal where the FDA can ask questions faster than anyone can answer them. Hence the rock fetching cycle until some one stops it.

More evidence of the FDA cultural change would be the declared new precision science practice declaration, before they had completely thought through HOW they were going to do it. And , do not forget the sudden stopping of all AD trials by BP after 20+ years of clinical work. (all voluntary of course). This and more is evidence of cultural change.

So, bottom line we are in the middle of a multi level technical/regulatory cultural transformation w/in the FDA with a process inflection point just passed. The future looks complex but when they get through this initial stages a much higher level of confidence in P2-P3 trials outcome should be seen. It just sucks being the test case.