Anavex Life Sciences Corp (AVXL)

[nidan7500]

IMGN did get some valuable knowledge out of that trial, it wasn't a total fail

OK, appreciate the corrective message.

My concerns remain around time being lost. Sometimes it looks like the process just (is what it is), follow the rules and wait till we say go.

No wonder Dr.M. has been looking for a better process where he can at least apply influence and judgment on how things get done. Clearly also some sense of urgency needs to be shown in fixing the cycles and pass/fail thinking. AVXL have been up front in saying the trials are used to verify what we already know/understand in a broader context (or words to that effect). We are not waiting for the FDA to tells us the drug works, our evidence already shows that, this is just a formality we must follow in order for them to agree with the methods used and inspect/monitor the verification process. (prove by review of objective evidence that BLAH-BLAH) This is NOT the same as (discovery)see if it works trial and error blah blah. If we can see that, why can't they? This verification will then be used by FDA and others to declare it is "Safe and Effective". I expect DR.M. has chosen an FDA licensed lab/house to produce and store the A2-73 being used. It should therefore require a records review and we can move on. The CNS diseases are complex beyond the understanding of most humans (including me). But, most of us can spot a flawed process when we see one. The bottom line is, waiting for a regulatory body to tell you pass/fail is just wrong. IMO.