Anavex Life Sciences Corp (AVXL)

[nidan7500]

The FDA is between a rock and a hard place. Damage control by the FDA IS the reason for the delay.

Yup, any of us who have interfaced w/FDA or other government regulatory bodies would know that most protocol lists of topics/process requirements to be addressed in each application has been used to wall in the city. They become a compilation-listing everything that ever went wrong. I am not being critical of FDA or employees. It is what it is. This is not about BLAME, it is about developing and applying an effective process. That has to be tough when the root cause of the CNS diseases they are testing for is completely unknown. No one knows...it is a blank piece of paper.

OF COURSE THEY WILL ASK MORE QUESTIONS. That is the process, that is how the FDA does work. BUT, at some point someone has to lead and take a risk decision b/c we do not know what we do not know. If they knew what caused CNS diseases this entire process would be much faster and the outcome more certain.

As Dr. Peter Senge would say.. " Someone has to see BOTH the forest AND the trees." People in the FDA do not get paid to take risks, in fact they might get punished. This point in the evolution of CNS diseases requires leadership to break the mold. We simply do not have another 100 years to continue w/trail and error methods for CNS diseases. I do not blame Dr.M. for keeping low profile nor FDA for doing it's job but someone will have to blink. Science should prevail but who will connect the dots w/o trials getting started? I thought RETT as a choice was brilliant by Dr. M. for short term biomarker verification purposes and still think that. If PDD is plan B, OK but who has the authority to intervene when we need it?