Anavex Life Sciences Corp (AVXL)

[nidan7500]

bear77...thanks for this..

[excerpted Dr Gottlieb’s statements in Sept 2017:
https://www.fda.gov/NewsEvents/Speeches/ucm575400.htm

“Our goal is to see how we can accelerate methods that improve our ability to use advanced tools to meet FDA’s gold standard for regulation.

These methods are being applied to both common and rare diseases. FDA is also collaborating with scientists to use similar computational tools to develop natural history models, based on placebo arms in Parkinson’s disease, Huntington’s disease, Alzheimer’s disease, and muscular dystrophy. If we’re able to make better use of rigorous, reliable natural history models, especially for rare diseases, it can help make clinical trial recruitment more efficient.”]

What jumps off the page for me here is ...The FDA (regulatory body) is willing to accept the responsibility to interpret and to decide what actions to take based on tools/knowledge and courage. Old schoolers buried themselves in meaningless rationalizations and basically FEAR (jobs/what if/career/statistics) . Unless the answer was 100000% clear in black and white they would hide in the layers of the process...we all now it when we see it. Meantime people died.

NOW, we have people like Dr.M. who floats an hypothesis on CNS homeostasis and is willing to bet his life on proving it. We have Dr F who left a big FDA job b/c he liked what he saw, We have Dr. G and Ms. Woodcock and who knows how many other heros who lived the old school way and are now on board. Well you know what I am getting at...it is called CHANGE and LEADERSHIP...what a concept.

In my previous position I would always make it a point to call out leadership and commend it whenever I saw it. It was often not PC to do so...and that was before PC.

I would tell people and I think it is true in this case with AVXL (a good reason to own it IMO). "Leadership is like pornography, it is difficult to describe , but you know it when you see it".