Anavex Life Sciences Corp (AVXL)

[nidan7500]

Gator328

Nobody knows how this investment will play out until the FDA makes a decision.

Why are AVXL doing trials in UK, EU, AUS...outside USA? We get that the USA FDA as gold standard is an historical fact but, for decades ISO standards established trans/approvals of FDA regulatory requirements and other international Verification and Validation methods-practices how is this an FDA exclusive choice?

Agree, The FDA has established a long standing position of/for WW excellence in detailed documented process/cGMP/Medical device (how to) leadership BUT the leadership have also held onto Amyloid Plaque thesis long after decades of failed work. The expression, "You cannot shine SHAT", comes to mind. . Obviously, any approvals of AVXL treatments for the largest CNS diseases WW conflicts w/the politics and practices of current FDA leadership. They are not about to fall on their swords.

The thinking that Bio-Pharm is not approved for WW/USA treatment-use unless and until the FDA says so, is not valid, IMO.