Anavex Life Sciences Corp (AVXL)

[falconer66a]

Failure of All Three Clinical Trials

At what point do you get concerned???

Fact is, Anavex Life Sciences Corp will be a revenue-generating, profitable pharmaceutical with the successful conclusion of just one of any of the three clinical trials being arranged and conducted. If any one of these proves successful — minimal or no adverse events (side effects), coupled with any sort of symptomatic stabilization or improvement — Anavex 2-73 will gain regulatory approval for medical use. Twenty-first century medicine thereafter will never be the same.

But, what are the chances of sales approval for one of the three central nervous system conditions being tested? Extremely high.

Think not? Find and present any evidence, either murine (lab rodent) or human even hinting that Anavex 2-73 fails to reconnect and restore normalized neuron functions. There is none. Quite the opposite. A multitude of murine studies show efficacy, affirming the mechanism of action of the drug, the re-connection of disconnected mitochondria with their normally-connected endoplasmic reticula. With this re-connection, facilitated by Anavex sigma-1 receptor agonists, neurons function normally. The disease state is obviated.

I make the challenge again. Find and present any laboratory or clinical evidence that the Anavex mechanism of action does not actually occur; that the company’s sigma- receptor agonists don’t really restore neurons to a pre-disease, normalized state.

Or, try to find a human with professional competence who will tell why the Anavex molecules can't work as claimed and demonstrated in murines (or humans). The silence of the matter is telling.

If the Anavex sigma- receptor agonists actually failed therapeutically, this would be easily confirmed in lab rodents with parallel or transgenic central nervous system defects equivalent to those in humans. Simply, there are no lab rat or mouse failures of Anavex 2-73 therapies when applied to appropriate CNS conditions.

The problems are not with the Anavex mechanism of action. The problems are the many regulatory and procedural complications of required to affirm safety and efficacy in humans. But with time (several years?) those will be resolved. It took over a decade for penicillin to come to market. In the modern era, it may take Anavex half a decade for its sigma-1 receptor agonists — with far greater influences on medical practice and therapies.