Anavex Life Sciences Corp (AVXL)

[frrol]

A bit more on odds ratios. There's a good reason that the standard primary outcome gauge for CNS clinical efficacy endpoints is mean change, not odds ratios. Odds ratios were developed to determine relative treatment risks, not efficacy vs placebo.

Biogen did not cite odds ratios as the proof of efficacy for Aducanab; it accompanied (followed after) the mean change results. It did not even provide odds ratios for Lecanemab. That was mean change. This goes for other AD, PD, FTD, etc treatment trials.

Missling said on Monday that use of odds ratios is "quite standard" in clinical trials. It's just not. In fact it is quite rare.

This is an endpoint fumble, similar to Rett AUC. There the fumble was just the late surprise, and no accompanying graphs of the curve. He did provide some justification though, that AUC was approved by FDA. Here it was a late surprise, no curve graph (by Monday they could have done that), and apparently no regulatory approval. No 'surprise' on that latter issue: the FDA is not going to care about an odds ratio.

Missling justified using odds ratio by emphasizing that we are looking for "clinically meaningful change for patients." Just show the ADCS mean change, Chris. It would show that.

There's mathematically a good chance our ADCS change to placebo is stat sig. Circumstancially it's a low chance. But it needs to be included.