Anavex Life Sciences Corp (AVXL)

[falconer66a]

Good question --- long term safety.

Falconer, in your opinion are we free and clear from all safety issues?

I can't imagine any long-term side effects. Were Anavex 2-73 a hormone-like molecule affecting endocrine or immune systems in any way, yes, chronic adverse events would be a concern.

But there is no evidence for this whatsoever. The Anavex 2-73 molecule has no resemblance to, nor mechanism of endocrine or immune disrupters.

It's ability to restore normalized neuron function, restoration of normalized homeostasis, if anything, would normalize, not degrade the chemistries of other cell types.

Two strong lines of safety data exist. First, that of the hundreds of rats and mice heavily dosed, at lengthy periods with Anavex 2-73. Long before any P1/P2 human trials for safety are ever undertaken, lab rats and mice are loaded with the trial drug, at lengthy periods, to detect possible adverse events. Tort law virtually requires this. Were some drug company to dose a bunch of early trial humans with a new drug, and severe, debilitating adverse events were to occur --- in the absence of any preliminary murine tests for such, the medical tort lawyers would make a fortune.

Ya simply can't be dosing naïve humans with a new potential drug until you've first done a detailed Ames Test (mixing the drug with bacteria, to detect DNA disruptions), and a host of other standardized toxicity tests.

Then, load rats and mice with the proposed drug. Measure vital signs, etc, to see if they have any adverse outcomes. If none of any of these, then P1 trials can begin on humans, watching everything carefully.

That was done in the Australian trial, with no near-term side effects of consequence (second body of safety evidence). Chances of long-term adverse events, after several years of treatment, highly unlikely.

But listen to the lengthy list of often lethal side effects of the drugs advertised on the Evening News. They were all approved and continue to be prescribed.

I just don't see this as an inhibiting factor of any present consideration.