Anavex Life Sciences Corp (AVXL)

[Hosai]

"I have never seen anything here or elsewhere that makes it demonstrably legit replacing a confirmatory RCT in a neurology indication like AD with an OLE"

It's an OLE showing both a stat sig delayed start analysis for both the primary endpoints, as-well as the more standard OLE analysis of against what would be expected, for AD against ADNI. Therefore is certainly meaningful OLE data despite obv not as good as another placebo controlled. They do have some cross trial support in efficacy from the PDD trial where sigma wt did better again and episodic memory better with 0.003 p value plus other stat sig cognitive measures.

Technically the MABS in their phase 2s were only strongly significant in removing amyloid. For other endpoints such as ADAS COG, CDR SB and ADL they mostly trended in right direction but weren't stat sig so whether you could argue they have replicated their results is up for debate other than removing amyloid. The did also replicate the brain volume loss and ARIA.
It's not cancer but is still a very serious terminal condition hence part of the reason the MABS were approved despite their bad safety.