Anavex Life Sciences Corp (AVXL)

[nidan7500]

An unintended consequence of new FDA process position w/precision medicine.

“The selling was apparently stoked by perceptions that its timeline for filing a U.S. marketing application for spinal muscular atrophy (SMA) Type 1 could be delayed.”

Apparently, the FDA required further information on the Ph3 trial and the back and forth which I speculated was happening between Anavex and the FDA, just as with the USPTO, and all regulatory bodies, is NOT CONFINED to Anavex, nor its leadership. It’s a fact of life that no one cares to mention - bureaucracies are NOT GOOD but they have good intentions*.


Just wanted to cite a current example from a Big Pharma to show that our company is not inept and our science/compounds are not snakebit. It’s a process. Roll with the punches.

We’ll get there. We are getting there.

I have spent my share of time dealing w/this kind of process change and also w/FDA rules based thinking. A likely unintended consequence of the new FDA guidance will be this kind of fetching rocks delay. Some will be questioning a path which requires discussion only and some will be second guessing. Dr.M has previously lead with his plans to demonstrate efficacy and safety and be done by PIII, instead of the full drama of past protocols. That presentation puts us in the position of doing some early deep dives along w/FDA. IMO, eventually this new process will result in fewer trials and fails. Complexity typically begets complexity, unless leadership intervenes early and effectively, which takes stones. We'll see.

I hope someone asked the FDA what the hell they were thinking of with multiple 20+ years of AD TAU trials resulting in continuous fails. They are snake bit.The inference engines in new AI reasoning tools will serve to highlight trial paths but only after the model has been populated with knowledge we do not have yet. Expect delays.