Anavex Life Sciences Corp (AVXL)

[falconer66a]

Not dots; only double-blind clinical trials.

Will the FDA, NIH, CDC or other (either public/academic/other) medical brain trust connect the AVXL MOA CNS disease trial dots or will we have to point that out to them?

Won’t be either.

In modern 21st century medicine connected dots are never the basis for new therapeutic approaches. They merely ‘suggest’ that some big, double-blind clinical trials should be conducted, primarily to “prove” that the connections are false, do not, in fact, support or allow the new therapies.

Connected dots do not constitute modern “evidence-based” medicine. The only evidence that can be accepted is the statistically-significant evidence produced in a large Phase 3 clinical trial. Often, that isn’t enough. The clinical trial must be replicated “to be sure.”

All of this is even more difficult when the connected dots create a graphic figure that doesn’t appear in any med-school textbook; when the involved modalities conflict with “what is known.” Such is the great problem with blarcamesine and the other Anavex sigma-1 receptor activators. They go against everything known about the CNS diseases they target. The notion (a big smeared dot) that some extraneous molecule can bind to the sigma-1 receptor protein and thereby facilitate or modulate a diversity of favorable cellular processes has no description in any med-school textbook. Too good to be true; therefore must be a falsehood.

Even with positive clinical outcomes, as presently the case with blarcamesine against non-pediatric Rett syndrome, there will be no quick white coat boarding of the Anavex train. The medical powers that be see that train stuck on a sidetrack somewhere, absent any truly substantiating clinical results.

I’ve posted on this before. In all the world, there are two professions that over the centuries have resisted new knowledge, understandings, and practices: medicine and agriculture. For medicine, the thalidomide disaster will never be repeated. Every drug will require proper clinical trial results; not merely some cerebral connecting of extraneous dots; no matter how big, hopeful, or precise those might be.