Anavex Life Sciences Corp (AVXL)

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But Sigma-1 Receptor Agonists Are Not "Regenerative"

The new regenerative medicine protocol (RMAT), has had 11 designations since oct 31st. Isnt this proof that the FDA is moving forward prior to official/public released guidelines?

Of course, under the Cures Act, FDA is moving lots of things forward, rearranging the chess pieces on the approvals game board. But, clearly, none of those changes are in any published, complete form. A work still in progress.

It is a stretch to presume the Anavex technology or mechanism of actin as 'regenerative.' Commonly, regeneration in biology refers to the creation or synthesis of totally new tissues or organs. Anavex molecules do not do this, by any definition. They do restore normal cell functions, the restoration of "homeostasis," the normal feedback and response interactions that maintain normal functions, keeping them from over- or under-activity.

Restoration of intracellular homeostasis is not "regeneration." No new, restored cells, tissues, or organs are involved. Hard to see how any new regenerative medicine protocols would apply to Anavex.