Anavex Life Sciences Corp (AVXL)

[nidan7500]

Jimmy...GREAT MESSAGE:

Anavex has a tough row to hoe but they seem to be doing so methodically and honestly. Let's see what happens and quit wringing our hands about natural and understandable delays. Ignore the Fear Mongers.

I would suggest we have many skilled observers and doers here who might be engaged in a useful task. This task is one I am certain the AVXL-FDA -RS scientists are now engaged in also as part of the IND/planning/juvenile toxicity, et.al discussion. The discussion must be about RISK MANAGMENT. Instead of hand wringing.

It is commonly understood that risk is defined as the combination of the probability of occurrence of harm and the severity of that harm. (AKA-what could go wrong and if it did what would happen?) Achieving a common understanding for risk management among diverse stakeholders (AVXL/FDA/RS?) is difficult for all the obvious reasons. Normally the FDA will look for evidence the risk management process has included this sequence (that a risk management process is established). Risk management Sequence: Risk identification, risk analysis, risk evaluation, risk reduction, risk acceptance then risk review...). The tools and processes for conducting a properly done risk management process would be reviewed by FDA inspectors. Not all risk will be eliminated by the process but a level of agreement on acceptable residual risk is required along with how this/any risk will be monitored and controlled.

Another consideration IMO has to do with how these science/lab development processes may begin to operate in their own time-space continuum bubble. It is Science Uber alles...we do not care about your clocks from the outside world. When we are done we will let you know. Getting everyone synched up takes time. I am sure they are working on this stuff and that we will get some more insight next week from the conference.

In the meantime anyone w/information on how any RETT pre IND past actual juvenile toxicity protocols have worked would welcome.