Anavex Life Sciences Corp (AVXL)

[boi568]

Most of my confidence arises from the previous Rett trial results which, as we know, hit its endpoints. This trial is using the same population as the first; the only difference is an increased dose. There is no evidence available that increasing a dose of 2-73 (within tolerance limits) will do anything other than increase efficacy.
We don't need an increased efficacy to pass the trial, we just need to avoid a drop below the endpoints. We survived the interim peek safety check.

Beyond that, we have biomarker consistency between PDD and Rett, even though the traditional etiology of these conditions appears qualitatively distinct -- that is, unless you accept the radical idea of a previously unexplored upstream cause. We have that too, in theory and now to an early degree in practice.

By analogy, you can look at PDD and AD. There is a 70 percent correspondence there for episodic memory. There are stats on the chances of success moving from a Phase 2 to a Phase 3 trial, which I believe Missling cited -- using precision medicine -- at 68 percent. If I remember my research correctly, safety issues account for 17 percent of failures in Phase 3 and commercial concerns another 5 percent; these risks are very minimized, if not eliminated. I can't parse all the overlaps involved in these elements, but it does seem to me like the AD chances of success are at least 90 percent. (My gut feel is iffier, but that is where the numbers point.) And the theory of efficacy, I believe, will apply equally to both Rett and AD.

So considering all this, I think 90 percent is a reasonable prediction for AVATAR's success.