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Tuesday, 07/26/2016 2:53:26 PM

Tuesday, July 26, 2016 2:53:26 PM

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2-73 will not be a “cure,” by any means; BUT....

No, a course of 2-73, causing endoplasmic reticula to physiologically reconnect with mitochondria and restore normal neuron function in Alzheimer’s, Parkinson’s, or other neurodegenerative diseases, will not be a cure. Stop the 2-73 therapy, and whatever originally caused the ER/mitochondrial dysfunction will resume.

Same way with diabetes. Insulin injections can control blood sugar levels, approaching normalcy. But stop taking the insulin and diabetic symptoms will resume.

The implications? Those for whom 2-73 is efficacious will not be taking the drug for a restricted period of time. It must be administered for the rest of their (then) longer lives.

In fact, this is exactly the sort of drug profile Big Pharma want to concentrate on; on drugs that require continuing, long-term administration — yielding continuing, long-term revenues.

Case in point. Multiple drug resistant bacteria are proliferating. But Big Pharma conducts very little or no research on finding new antibiotics. Takes lots of resources and time to find and synthesize the new antibiotics, but if they are effective, the simply kill off the bacteria in a restricted period of time. No long-term, continuing revenues from those being treated.

Not the case with Anavex 2-73. With, perhaps, 5 million Americans affected by Alzheimer’s, each patient will be taking 2-73 for the rest of their days. THAT’s long-term revenues.

Now, of course, astute minds will point out that we presently have no evidence that 2-73 will be continually effective, with no loss of efficacy over time. Will 2-73 lose efficacy after a certain period? Only long-term administration and monitoring will determine this.

This, generally, is why advanced, long-duration double-blind Phase 3 trials, with both experimental and control arms (some with the drug, others without, just a sugar pill) are usually preferred and required by the FDA.

But, in animal trials, and in the short human trials (to be announced tomorrow), it is expected that profound positive results will appear (they already have in the animal models). With the absence of adverse effects, in both murine (mouse) and human trials, there will be no reason for the FDA to require double-blind Phase 3 trials. Early “compassionate approval” will be justified.

Personally, I have every reason to believe, based upon (among other things) the 2-73 molecule’s ability to so easily cross the blood/brain barrier and enter dysfunctional neurons, uninhibited by normal toxin-clearing or immunosuppressive functions of the body, it will continue to work favorably for extended or continuing durations.

With all of that a) Anavex (or a collaborator) will reap gigantic and continuing revenues, b) shareholders will be richly rewarded, and most importantly, c) millions of patients will live normal lives.

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