I am beyond wishful thinking. I am basically a process guy trying to figure out what step is next and what sequence makes to most sense. There at least 2 big issues for me in working the problem solving process. 1. No one in charge. 2. The problem statement is not defined (there are many different ones). I will then assume the FDA is in charge and the problem statement is :There is no effective treatment for numerous CNS diseases including but NLT(AD,PD,MS,PD,RS and others).
The FDA has demonstrated no skills in identifying and initiating scientific investigations of CNS diseases (lots of evidence of this).The FDA would explain that is not their job.
Since the FDA has not been leading the CNS disease treatment process has defaulted to the private sector which is motivated by cost/benefit and sp appreciation.(sooner the better) This results in mixed episodes like the one (AAIC 2018)we just went through where SP is driven sky high and then crashes. No CNS patient benefits by sp drives directly, in fact they are hurt b/c new possible treatments do not get attempted due to perceived market environment risks. The FDA does have lots of rules/processes and controls but they do not ensure solutions, only costs.
The CNS solution process runs on money, which may/may not be tied to good science or effective treatments. The motivation loop between patient need and science effective treatment cannot be closed w/o money in this model. If AVXL solutions are going to be understood and effectively applied it will only be because we add money. Some kind of partnership is the best/quickest money path. This path also leads to better visibility which then reinforces the money link. This process tends to be self reinforcing where money/begets more money when the science is proven to be effective. More money-to-more initiatives-more trials-more knowledge-more trials-and so forth.
In this process, the only path to effective CNS disease problem solving involves money. The more money, the more processes, etc. Sadly, control of the solutions and control of the money appear to currently have contradictory leadership visions. Partnering ASAP is the best solution.
