Anavex Life Sciences Corp (AVXL)

[nidan7500]

Big P uses the FDA to stay out of jail. The FDA uses processes, committees and experts, documented-step x step rules based (sit in a room and debate) rules, all of which must be followed. The rules are nominally based on .."The List of everything that ever went wrong"...which is sacred to all such functions. There is always some guy in the room who will point out "WHY it MUST BE SO".

Even when great concepts are agreed to the next step is to write it all down and to develop the sequence, check points, test criteria, etc. They can not help them selves.

The FDA feels obligated to do what they have always done(rules based processing) to keep a big mistake(ref. thalidomide sp?) from causing harm and to keep their jobs. BP does basically what they are told after the obligatory debate. (This is how labels and labeling were born) It is nothing new,the technicals vs the process guys. Gottlieb and M should have known better before they opened their mouths describing what was "POSSIBLE", before the process guys got wind of it. "Sure-go ahead-break all the rules"...see you in Levenworth prison.