I believe Anavex has learned from its clinical trials and stumbled on the right approach. I have followed Anavex for many years. The DNA/RNA knowledge Anavex has acquired explains how homeostasis is restored in patients suffering from disease - especially CNS diseases. AVXL 2-73, I believe, does not treat these diseases directly, but the drug apparently puts the body in the position to repair or attempt to repair itself by restoring the DNA/RNA function - hopefully before too much damage has been done that may be beyond repair.
However, as it has been said before, it’s all about the dosing. Anavex needs for dosing to be optimal for its various patients. Dosing has to be large enough to have a significant effect, but it must not be too large to have an adverse effect. It seems to me that it may also be important for each physician to be educated to prescribe the right size for each patient, which is done through drug detailing. Anavex has acknowledged that it will need to partner with a major pharmaceutical company to accomplish detailing of doctors for the large indications at least.
Labeling is also a hurdle in the approval process. Anavex will have a lot of work to do to get the labeling approved for each indication that AVXL 2-73 may treat in patients that vary in age, size, condition, genetic make up, etc.
To specifically answer your question, I am confident that AVXL 2-73 will get there, but Anavex has quite a bit of work to do to get it just right for approval of each indication and to launch the drug to treat these indications in children and adults, which means that it will take time.
