Anavex Life Sciences Corp (AVXL)

[jimmy667]

Valid question, however, I think it qualifies under paragraph "a."

Regenerative Advanced Therapy Designation

As described in Section 3033 of the 21st Century Cures Act, a drug is eligible for designation as a regenerative advanced therapy (RAT) if:
a.The drug is a regenerative medicine therapy, which is defined as a cell therapy, therapeutic tissue engineering product, human cell and tissue product, or any combination product using such therapies or products, except for those regulated solely under Section 361 of the Public Health Service Act and part 1271 of Title 21, Code of Federal Regulations;
b.The drug is intended to treat, modify, reverse, or cure a serious or life-threatening disease or condition; and
c.Preliminary clinical evidence indicates that the drug has the potential to address unmet medical needs for such disease or condition

(emphasis added)

A2-73 has been described by the company as "cell therapy" in that it seeks to re-establish cellular homeostasis by reconnecting the mitochondria to the endoplasmic reticulum. Working at the cellular level on the health of the individual cells as MOA rather than just improving the symptoms or clearing debris such as beta-amyloid plaques. Interestingly enough or one could say understandably it also covers BPs beta-amyloid approaches in that those investigational ligands are for the most part biologics.

But yes on initial reading I thought it was a "bone thrown" to BPs expensive to produce and clinically trial biologics. It read like it was referring to "biologics" on first reading, but consider the language I bolded. It clearly distinguishes between cellular therapies and cellular products (biologics) and includes themBOTH.

Great stuff and would definitely help in Dr. Missling's stated primary responsibility of managing clinical trial risk.

GoAnavex Life Sciences.