Anavex Life Sciences Corp (AVXL)

[dadofmarcmax]

The subtle shift in focus of AVXL should portend big things, as I have opined in the past.

2 years ago, it seemed that 2-73 was deemed to possibly allow for 1) stabilization of cognition in patients with mild-moderate AD, 2) slow progression of PD and perhaps 3) contribute to improvement in function with small gnificant decrease in seizure control for patients with Rett syndrome. Various uses for rather pointed, narrow and specific indications.

Fast forward and now with data, notice how less emphasis is on AD as AVXL has shifted to a much broader scope, that 2-73 restores cellular homeostasis and, as a result, there needs to be a double blinded, randomized pivotal trial that can "prove" this hypothesis by demonstrating that in seemingly varied neurodegenerative disorders, restoring homeostasis equates to demonstrative improvement in both objective clinical and biomarker measures relative to an untreated control.

So using data already known from the varied 2-73 studies already conducted, perhaps one comprehensive trial with a broad goal of demonstrating efficacy amongst several indications while putting into effect precision medicine techniques in the design of the novel study is why we have silence.

Whatever is to come, be prepared for a trial design that has never been performed with a broad primary clinical endpoint and multiple secondary endpoints. This is a unique molecule in terms of the many potential indications and, as such, a unique trial design that has lots of "meaning" is taking time. I, for one, will wait.

(Currently waiting on line to take the Chappaquiddick ferry back to Edgarstown as I vacation)