Anavex Life Sciences Corp (AVXL)

[nidan7500]

[quoteThe lack of implementation of trials has been blamed on FDA as well as any other excuse this board can find. ][/quote]

Blame is not the word we should apply here, IMO. The FDA is a regulatory body, they own the PROCESS for new product approvals/development. That process for CNS treatment testing/approval is perceived to have been ineffective for a long time (see AD). Some process users are beginning to address that need while the FDA has declared "precision Medicine guidance...on the way".

This does not have to be complicated, but it will be. Commercial, competition based, free enterprise understand this dynamic very well. "Lead, follow or get out of the way", is the way one group puts it. We can deal w/it...BUT if youFDA stand up and STOP THE TRAIN then you BETTER know when and how to restart it. This is a PROCESS ISSUE, that's all it is.