Anavex Life Sciences Corp (AVXL)

[nidan7500]

Perhaps the two timelines intersect, meaning that Anavex is utilising the wait for the FDA guidance documents to become official, with an assumption the company is well aware of their outline contents, to optimise their analysis

Agree w/this and would add that this is all about PROCESS...no blame needs to be assigned.. People, in this case the FDA, OWN the process. They control safety and effectiveness, as it should be.

All work is always done by processes. The FDA has not done an good job of monitoring the effectiveness of their CNS drug development/testing processes. That is all we suggest here. Blame is a word that goes no where and should not be used in this context.

The good news is, somehow they now appear to be aware of their responsibilities and plan to fix this. We have some anecdotal evidence they are doing that. The new processes will be based on new thinking and new tools. We should expect a roll out soon but also that there will be hiccups and delays. (IMO-A2-73 RETT is the Beta trial)The good news is, they now recognize the past failures and are taking corrective action, and there seems to be agreement on the problem statement.