Anavex Life Sciences Corp (AVXL)

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Yes, I’ve pondered this, the impossibility of blinding profoundly positive responses to 2-73 in any supposedly double-blind clinical trial.

Now, if 2-73 works slowly and moderately, it might take many months or a year or two before any symptomatic relief might be properly quantified. But there is not a scintilla of evidence that this will be the case; quite the opposite. Restoration of normal behaviors in transgenic dementia in mice has been rapid and rather complete. The two or thee humans who responded so well in the early (and short) Australian trials are examples.

I will not be surprised if the following occurs. When proper double-blind human trials of 2-73 are conducted on a statistically-significant number of humans clearly diagnosed with early-stage Alzheimer’s, it’s going to be very difficult to keep hidden to the patients themselves, their families, and care-givers the remarkable reduction of the symptoms that formerly portended miserable years for both the patients and care-givers. One needn’t be a trained geriatrics nurse to detect the restoration of normal, pre-Alzheimer’s behaviors.

The word will “get out.” Stories will be told how Grandma no longer needs care; she dresses herself, eats normally, converses as she did, and simply has no debilitating dementia since participating in the 2-73 trial.

If this were to occur with only a fraction of those in getting the drug it could be explained away as merely rare incidental outcomes expected on the positive tail of a bell-shaped response curve.

But I don’t think that will be the case. No animal data suggest responses on a depressed bell-shaped curve; rather, they are steeply ascending and rather linear.

The social implications of dozens of people in the trial “getting better” early on will be most interesting. With enough cases, media will jump on this, pointing out that the poor folks who drew the placebo arm of the trial are being screwed. They, too, need to get the drug.

Then, how many citizens will write heartfelt letters to their legislators claiming that FDA hesitancy in rapid approval of 2-73 creates horrible burdens on their Alzheimer’s relatives and care-givers? In the absence of side effects and adverse outcomes, the political pressures for FDA to grant compassionate approval of 2-73 will be great.

Will be engaging to see how all of this plays out. Gonna be tough for the clinics and clinicians to keep results “blinded.”