Replies to post #429354 on Anavex Life Sciences Corp (AVXL)

[Investor2014]

There were many remdesivir trials, but one of them is a good example of comparing one treatment against another to determine the odds ratios associate with one treatment being more effective and/or less risky than the other.

Effect of Remdesivir vs Standard Care on Clinical Status at 11 Days in Patients With Moderate COVID-19

Results
Among 596 patients who were randomized, 584 began the study and received remdesivir or continued standard care (median age, 57 [interquartile range, 46-66] years; 227 [39%] women; 56% had cardiovascular disease, 42% hypertension, and 40% diabetes), and 533 (91%) completed the trial. Median length of treatment was 5 days for patients in the 5-day remdesivir group and 6 days for patients in the 10-day remdesivir group. On day 11, patients in the 5-day remdesivir group had statistically significantly higher odds of a better clinical status distribution than those receiving standard care (odds ratio, 1.65; 95% CI, 1.09-2.48; P?=?.02). The clinical status distribution on day 11 between the 10-day remdesivir and standard care groups was not significantly different (P?=?.18 by Wilcoxon rank sum test). By day 28, 9 patients had died: 2 (1%) in the 5-day remdesivir group, 3 (2%) in the 10-day remdesivir group, and 4 (2%) in the standard care group. Nausea (10% vs 3%), hypokalemia (6% vs 2%), and headache (5% vs 3%) were more frequent among remdesivir-treated patients compared with standard care.

In the both Anavex AD trials patients are allowed to remain on SOC and here A2-73 has the extra challenge of beating placebo when SOC is also distributed in the mix of both placebo and treatments arms.

It is quite common in standard RCTs to allow SOC, but SOC does not change the nature of what is being tested and are not comparable to the correct use of Odds Ratios as in the above remdesivir trial.

The different purposes of a clinical trial and the appropriate use of Odds Ratios is key to appreciate why biotech investors and the market is currently not valuing $AVXL higher.

[Doc328]

OR is a valid endpoint for binary outcomes such as cure rate or infection rate for antiviral or vaccine. If performed for near continuous outcomes like ADAs-Cog or CDR-SB, it is typically a supplementary analysis of the outcome/scale not the primary endpoint.

[powerwalker]

sokol, participants continue their SOC and added blarcamesine.

For both groups (30 and 50 mg), there were ~2 of out 3 taking DPZ, with the rest being DPZ-naive.