Nidan, A very measured and astute analysis. The process of drug development from research to market is a process of low risk and liability avoidance. The horror story of Thalidomide lurks in the minds of public health officials and is the body of possibility of the product liability lawyers. So the process pits the adverse risk of the few against the certain death of millions. Big Pharma has been playing this game for years and their corporate thought process and their research mechanisms have been developed accordingly. Money, size, and minimal risk are the drivers of their drug development methods. They leave it to the small bio's to take the risk and buyout those who are successful, stepping over those who have failed.
IN my estimation, Commissioner Gottlieb understands this as a physician, businessman and former FDA Assistant Commissioner and now Commissioner. He also understands the patient's side as a cancer survivor. It is obvious, from what we have seen and heard, that he would like to change things at the FDA to make drug approval safer and more efficient. He also sees his role as critical to saving the country's health system (Medicare and Medicaid) and keeping healthcare from destroying the Federal Budget. Thus, he knows he has to stem the three great expanding medical treatment areas of Cancer, Alzheimers, and Cardiovascular disease. IMHO the Cancer COE and the ACTC are very positive steps in that direction and I think 2018 will see the FDA taking revolutionary rather than evolutionary progress. And this will be much to Anavex's advantage
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