Anavex Life Sciences Corp (AVXL)

[boi568]

What I didn't discuss was the thought that Missling misrepresented what he knows when announcing that all endpoints, including ADCS-ADL, had been met. I have given my reasons elsewhere why this one just makes no sense.

For some reason, you seem to believe that Missling should speculate on unpublished 50mg outcomes. That's also not something he has ever, or will ever, do. Like misstating endpoint results, it can only lead to trouble. But it's not fantasy to think that Missling has seen a rough cut of the pre-specified 50mg dosage arm results.

As for your belief that there is an AD trial size minimum at the FDA -- why? Trial sizes are not disease-specific; they represent the expectation of clinical effect. To date, even BP has low expectations for the clinical effects of the AD monoclonal antibodies. You see it in the large trials they are conducting (and the disappointing results those trials yield, with their expensively-purchased p values). The fact that the FDA wants 2000 participants from SAVA doesn't show much confidence in SAVA. I wonder why.

By contrast, Missling has an entirely different drug, and he has a lot more confidence in its efficacy. So he did not design a massive trial to tease out a small signal. We already have seen better clinical effect with a combined dose (!) compared to the BP candidates, justifying Missling's trial design. The rest of his data set will be revealed shortly.