Anavex Life Sciences Corp (AVXL)

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Where Might Anavex Fit?

Here’s the PDF’s listing of products regulated by the FDA Center for Biologics Evaluation and Research (CBER):

1. Blood Products
2. Vaccines (preventative and therapeutic)
3. Allergenics
4. Live Biotherapeutic Products
5. Devices Related to Biologics
6. Human Tissues and Cellular Products
7. Xenotransplantation Products
8. Gene Therapies

Which of these might accommodate any of the Anvex sigma-1 receptor agonists? Let’s see.

1. Blood Products
Nope. The Anavex molecules are not blood products; not produced with, by, or for blood.

2. Vaccines (preventative and therapeutic)
Nope. Anavex has nothing related to vaccines.

3. Allergenics
Nothing here, either. Nothing related to allergies.

4. Live Biotherapeutic Products
Again, nope. Anavex molecules are not “live.”

5. Devices Related to Biologics
Anavex molecules are not devices, physical structures.

6. Human Tissues and Cellular Products
Anavex does not produce anything from human tissues or cells. Anavex molecules are synthesized in biochemical labs, in vitro (“in glass”). Anavex molecules are not tissues or cells.

7. Xenotransplantation Products
“Xeno-“ means foreign or external. Anavex transplants nothing.

8. Gene Therapies
Lastly, Anavex molecules do not affect or target any genetic materials, DNA, chromosomes, nor any other.

Perhaps the company can petition the FDA for a unique, specific inclusion. But until that, the Anavex molecules don’t fit.