To answer your good questions.
Yes, additional human trials are needed, for several reasons. A conventional double-blind Phase 3 study, with an experimental arm (with the real Anavex 2-72), and a control arm, where a physically identical placebo is administered is needed. FDA rules require such for eventual drug approval. FDA is “protecting us.” They want to be as certain as possible that adverse events (side effects) are minimal and not disqualifying, and that the drug actually works, with regulatory efficacy. The previous Phase 1/Phase 2 study is inadequate for all of this — a matter I do not contest in any way.
My point is this. The existing murine and P1/P2 data, coupled with an understanding of how Anavex 2-73 restores normalized neuron function (its hard cellular biochemistry) all predict a very successful Phase 3 trial. The chances that the drug will prove non-effective in stabilizing or reducing Alzheimer’s symptoms, and/or prove to have disqualifying adverse events are, to me, infinitesimally tiny. Hence, I’m confident in the appreciating value of my early equity position in AVXL. Wish I could buy more shares.
You mentioned the heretofore unconsidered factors of insomnia relief and quality of life outcomes for both patients and care givers. I would add the many additional conditions Anavex pipeline drugs will treat; from cancers, psychiatric conditions, heart disease, to epilepsy, and a growing number of others. All of that will play out so favorably in coming years, for both patients and Anavex Life Sciences, I’m certain.
The magnitude of the Anavex medical revolution is unappreciated by most. Few are able to envision it, for several reasons. Commonly, Anavex’s Alzheimer’s approach is erroneously conflated and mixed with the dozens of failed amyloid suppression or removal trials of other drug companies. They all fail; therefore, Anavex 2-73 is likewise destined for expensive clinical failures, too.
Many others fail to understand Anavex 2-73's unique biochemistry and its ability to restore normal cell function. Too good to be true. Appears to be a mystical nostrum. Can’t be true, as future clinical trials will prove (so they think).
Then, Anavex Life Sciences is a pharmaceutical start-up, with no proven revenues, without even an FDA-approved product. The record for such companies mandates a very harsh assessment regarding any retail equity position. Therefore, it’s regarded as a long and potentially bad gamble by so many “experts,” both financial and scientific.
You mentioned the assessment of a placebo effect as a potential cause of clinical efficacy. Not a factor. Not a consideration. No one, ever, has been able to suppress or reverse the multitude of Alzheimer’s symptoms by willful or hopeful thinking.
Anavex Life Sciences and Anavex 2-73 are the real things.
