Anavex Life Sciences Corp (AVXL)

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The FDA Trump Factor

To the FDA, we are one of hundreds if not thousands of companies all vying for attention. We have to wait our turn.

The 21st Century Cures Act (Cures Act), signed into law on December 13, 2016, is designed to help accelerate medical product development and bring new innovations and advances to patients who need them faster and more efficiently.

https://www.fda.gov/RegulatoryInformation/LawsEnforcedbyFDA/SignificantAmendmentstotheFDCAct/21stCenturyCuresAct/default.htm

This is not your father’s (nor anyone else’s) FDA. The Swamp (as it were), if not being drained, is certainly getting stirred. Sit-around-and-ponder types, in every DC agency are getting the word. Get busy. Get things done, or retire. This get-things-done New York guy is running things now. Agency sloth and unproductiveness are being attacked and changed. (Check the recent “retirements” at US EPA.)

The 21st Century Cures Act is a congressional mandate to speed up and facilitate drug treatments and regimens.

Only a fool would think any and all of the important insiders at FDA to be ignorant of Anavex and all that that company can produce. Those who attach themselves to a prompt testing of Anavex 2-73 for the three indications will rise if and when any of those gain Anavex treatments.

For the moment, none of the three trails have begun simply because FDA hasn’t finalized the new, revised, facilitated test protocols. Once published, watch what happens.

Everything else is irrelevant, except for those with day-to-day, short-term perspectives.