Anavex Life Sciences Corp (AVXL)

[falconer66a]

Blarcamesine's Profound Safety Can Obviate Phase 4 Trial

I don't believe any P4 will be needed as the results will be convincing in and of themselves.

One of the several considerations requiring a Phase 4 follow-up trial is to ascertain the long-term safety of the new drug; especially attended to in novel new drugs acting in the central nervous system. It is well-known that drugs acting in the CNS commonly (almost universally) have long-term safety problems. Chemically addressing nerve and neuron functions can be inherently problematic. And many of those problems don't appear in early dosing periods; can take some time for them to develop. Hence, FDA's desire to see clinical data exhibiting chronic (long-term) drug safety.

Of course, the medial professionals making FDA drug safety decisions are not ignorant of neurochemistry. They can comprehend the chemical pathways and mechanisms new drugs impose on nerves and neurons. That's exactly where Anavex has an advantage. Not a single clinical trial of blarcamesine, in either murines (lab rodents) or in real humans has ever, at any dosage or duration, exhibited untoward side effects. Simply, and by abundant existing evidence, blarcamesine is profoundly safe. It does not in any way disrupt or compromise any bodily function or organ system. Plainly put, it has no consequential side effects, either upon immediate dosing, nor with long-term dosings. Common drug side effects have never been found: no disruptions of genetic processes or compounds, no endocrine involvements, no teratogenic (birth defect) factors --- or anything else. As the evidence shows, the drug's unique mechanism of action (MOA) precludes all of those problems.