Anavex Life Sciences Corp (AVXL)

[sokol]

Nidan: Just illustrating my cynicism relative to the drug approval and health care processes, which is sometimes motivated by self -interest as I believe the opioid fiasco is a prime example. As you probably know, the FDA approved a change in opioid labeling to provide for around the clock administration of opioids after holding private meetings with major pharmaceutical companies and without requiring clinical trials to demonstrate safety. The general public should be outraged, but I do not see evidence of that. In the meantime, badly needed and potentially beneficial drugs have demonstrated safety but remain bogged down in the FDA approval process. People should be asking why hold a private meeting at the FDA and approve more frequent opioid use without even requiring a safety study for those additional doses during each day. Moreover, we should demand to know why the FDA may be motivated to meet privately and expedite such a request for opioids when that sort of treatment is not available or extended for drugs that may treat Alzheimer’s and other serious CNS diseases that are becoming rampant in the United States and elsewhere.