Anavex Life Sciences Corp (AVXL)

[dennisdave]

You are comparing apples to planets, not apples to oranges.

Those “two mAbs” are not examples of CHMP flipping a clearly negative trend vote into an approval during re-examination.
Those mAbs succeeded because they had solid RCT outcomes. They had: powered Phase 3 trials, predefined endpoints, statistically significant results, reproducible signals, clear disease-modifying or symptomatic benefit. The Anavex AD trial had none of that.

These are examples of borderline dossiers with strong primary-endpoint hits where the initial CHMP hesitation was about risk–benefit balance, safety, or population definition, not about lack of efficacy as in the case of Anavex. Re-examination almost NEVER overturns a refusal based on insufficient efficacy. This is the brick wall Anavex hit.

As Doc and Investor have pointed out many times, Missling should have focused early on the specific Alzheimer’s subgroup where A2-73 actually seems to show a real signal, and then run a properly designed Phase 3 trial in that defined population. Instead, he went for a broad, unfocused pivotal trial and tried to force a full Alzheimer’s label based on post-hoc analyses from a weak study. By overreaching and chasing a “one-trial approval,” he essentially sabotaged the program. It was a major strategic failure.