Anavex Life Sciences Corp (AVXL)

[nidan7500]

jimmy:

One might conclude that expensive trials for expensive to produce drugs were driven in part by the “justify the price” culture of the third party payor system.

You might be right about the culture being one of the outcomes of the process. I would suggest some smart people saw quickly how they might make money and control the system of trials while the FDA had no motivation to change(WHY???that is the mystery to me). In any case, the process model is there to analyze. If FDA saw itself as principally responsible for(safety and efficacy) then the emphasis was on write rules/make sure they are followed, which is what regulatory bodies do best. Insurance companies and BP went along.
My issue is the symptoms of the process not working were there for decades as in failure to produce and effective treatment. So...they moved the goal posts a little and carried on w/various AMYLOID PLAQUE trials/SOC and carried on for at least 20+ years w/very limited evidence of real progress towards a real solution.
AD is a real problem which now is shaping up to be a CNS-HC Budget disaster. The AD non solutions are a process failure and not of the people doing the work, except that they let it happen. One could argue that the Amyloid Plaque thesis continuous failure is a symptom of poor policy/process. Obviously the system was not self correcting nor was it properly monitored by FDA, who will punish-kick the crap out of any CFR part XX supplier found not to have effective self monitoring CAPA systems established.