Anavex Life Sciences Corp (AVXL)

[falconer66a]

FDA Fast Track Designation

https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM358301.pdf

Apparently (from a quick read-through), Anavex 2-73, as a treatment for Alzheimer’s might qualify for FDA Fast Track designation.

But first, it appears that the same, conventional safety and effectiveness standards required for non-Fast Track drugs must be met, including “well-controlled clinical investigations.”

Page 19 tells a bit of what’s required:

Evidentiary Criteria for Accelerated Approval

Drugs granted accelerated approval must meet the same statutory standards for safety and effectiveness as those granted traditional approval.20 For effectiveness, the standard is substantial evidence based on adequate and well-controlled clinical investigations.21 For safety, the standard is having sufficient information to determine whether the drug is safe for use under conditions prescribed, recommended, or suggested in the proposed labeling.2

Page 28 tells how to apply for Fast Track designation:

This appendix describes general processes applicable to the submission and review of fast track, breakthrough therapy, and priority review designations.

So, if Anavex wishes to gain Fast Track designation, they will have to apply for it. But it appears in doing so they will have to provide data from conventional clinical trails demonstrating safety and effectiveness. The data from the Australian study are almost surely inadequate. The up-coming large Phase 3 study may be required.

These regulations appeared three years ago. To date, Anavex has elected not to pursue them, probably because of their requirement for conventional safety and effectiveness data, from an adequately-sized, and probably double-blinded study.

Apparently, no Anavex Fast Track designation until after the up-coming Phase 3 clinical trial for Alzheimer's, yielding the required clinical data for Fast Track status.