Anavex Life Sciences Corp (AVXL)

[polarbear77]

This Reuters article from February 2018 spotlights how global regulators are now planning to assess new Alzheimer’s Disease drug candidates. https://www.reuters.com/article/us-healthcare-alzheimers-europe/europe-follows-fda-with-plans-to-help-early-alzheimers-drugs-idUSKCN1GC2BU

It’s NOTABLE how today’s announced Anavex 2-73 ph 2/3 AD trial has these new precision medicine & (use of) biomarkers aspects.

Makes a lot of sense as to why Anavex did not rush the start of this new AD trial in 2017 prior to the release of these new worldwide guidances in 2018.

Small cap biotech pioneering the new CNS disease drug trial frameworks by utilizing precision medicine and biomarkers and full genomic analysis.

We seemingly just needed time to complete the Ariana pk/pd and Illumina genomic analyses over the past year.

And WISELY Anavex awaited the new 21st Century Cures Act CNS Disease trial guidelines promised by Dr Gottlieb back in September 2017 before finalizing our new trial framework.

Article excerpts:

“European regulators are following in the footsteps of the U.S. Food and Drug Administration with plans to help pharmaceutical companies win approval for novel Alzheimer’s drugs that treat the earliest stages of the memory-robbing disease.

The European Medicines Agency said on Wednesday its new guidance would encourage the testing of new medicines even before symptoms appeared, as well as the potential use of biomarkers, such as signs of protein build-up in the brain.”

And,

“Scientists and drug company executives have welcomed the rethink on both sides of the Atlantic, which was kicked off by FDA proposals on Feb. 15.”