Anavex Life Sciences Corp (AVXL)

[nidan7500]

It is not the FDA's job

The "I just work here" style of management is what resulted in the FDA being able to stand by as millions of AD patients rot in AD treatment warehouses.

Do some DD and you will understand that the FDA routinely rejects and sues suppliers/prevents drugs and medical devices from sale that are not effective or adulterated every friggen day. They own the process (CFR) and investigate the detail for every licensed product supplier (medical device/pharma/combination product) sold in the country.The supplier is responsible to present a case/proof of efficacy and science validity. The FDA is responsible to verify the proposal is medically effective and it is in control. (the task is proof of efficacy here) They CONTROL THE WAY THE PRODUCT IS MADE, INCLUDING DESIGNS AND MATERIALS USED AND HOW IT IS MADE AND ALL DEFECTS. They look at all complaints and adverse events reported and investigate every single one. The key words here are SAFE AND EFFECTIVE, that includes design and control.The I JUST WORK HERE is an irresponsible position to have. They have finally been stopped and told to follow (create) a process which involves proving that a method or practice/product will be effective (Before they try it on humans). What a concept. I argue that the people who ran the previous process should be held legally accountable for the last 20+ years of repeated failures. Someone is responsible but it will not happen b/c the SWAMP is TOO DEEP. This is only the tip of the iceberg.

When a process does not work (such as decades of failed Amyloid thesis AD trials) someone must ask the question..."Why do we have continuous failures?" "Could it be that the Amyloid thesis is just wrong?" . But no one did, The FDA failed to perform any CA review. That is BASIC stuff. Sponsors and FDA are responsible for the investigation process which is based on some premise of cause-scientific method and causal analysis. They own it. They are NOT JUST OBSERVERS, as much as that would help an observers position, it is just wrong and is consistent w/ an incomplete understanding of the requirements. Thankfully, someone (DR G.) finally was put in charge who told them all to stop, there is a new sheriff in town. except for BIIB they all took the hint. Eventually, they were going to be sued (consent decree's are done every day) and prevented from exposing any more patients to a trials process which was statistically pointless and medically criminal. That is reality, something a lot of people in government don't get.

BTW, I have no personal bone to pick w/anyone. The incentives to run trials as a method of proof has been overwhelming. " Maybe if we run enough trials we will get a winner."We got exactly what should have been expected. Just more of the same.