Anavex Life Sciences Corp (AVXL)

[nidan7500]

https://www.fda.gov/Training/GuidanceWebinars/ucm367786.htm

you are saying that the FDA failed to tell the drug companies what research they should be pursuing. Do I have that right?

Not exactly, FDA repeatedly failed to set proper criteria and controls for AD trials and to assess the ongoing risks. Continued Amyloid Thesis based trails failed to manage patient risks. No evidence of a feedback process or CA process. At some point a responsible FDA manager should have called a halt. Finally they did that(see Dr.G. finally called P.M.).

Read the guidance doc linked here from the FDA website, it is embarrassing to think this is what they could do/tell inspectors and clinical practitioners. They clearly state they have no criteria for AD trial pass/fail. But, they repeatedly ran trials anyways.

I am saying (w/your process background you will certainly understand)the FDA tells everyone to follow a few basic rules for all important processes according to the complexity of the process and the importance of the process to the product (in this case trial process was their product) being produced.(see 21CFR part 820(210/211 same) cl 820.100 basic stuff.
a) establish and maintain...corrective-preventive action procedures.
paraphrase follows:
1.FDA must Analyze processes...complaints...and other sources of complaints, and other sources of data to identify ...existing and potential causes of NCP ….other sources of data to identify existing or POTENTIAL causes of ...or other problems. Appropriate statistical methodology shall be employed to when necessary to detect recurring quality problems.

2. Investigate the cause of NCP (AD trials process is their product)
3. Identify actions needed to correct and prevent recurrences…

I do not want to use your time on this basic stuff but we should agree that the FDA has an obligation to at least follow it's own requirements.

In this case, their product is the trials process being used. They continued to support and initiate AD trials when they admit they had no acceptance criteria and in fact were out of control. (see text-guidance)

Someone in the FDA should have said we are out of control, we cannot conduct another AD trial until we establish some basic trial process pass/fail criteria. When 99% of the trials fail, you do not have a process nor the right to keep going until you fix your own process. Now, with PM we are heading down a different path which is at least based on some solid science and acceptance criteria.
Fortunately AVXL has come forward with pass/fail criteria which are measurable and based on strong science. I am sure you will agree this is basic stuff. Had FDA been honest and stopped Amyloid Thesis trials 10-20 years ago after repeated failures, PM would have happened sooner.