Anavex Life Sciences Corp (AVXL)

[Doc328]

I don't think Anavex would have chosen to present bad data at an international conference -- especially the same day that aducanumab has its Ad Board. CTAD's decision to grant a LB session has more to do with a desire to get new clinical data in front of the audience than a concern about the actual results. Negative studies can be at an LB session (though with the 273 PR this is not expected)

The data has a wide possible range from not terrible to ok to good to great. This data is not going to be a pivotal study for the FDA/EMA so they can present the data with a spin. Missling promised clinical significance so at least one result will have a p < 0.05, presumably for the primary endpoint. Often, secondary endpoints have better values than the primary endpoint --- maybe the entire CDR battery score is more significant than the CDR-COA primary endpoint.

Once data is out, methods of analysis can be evaluated -- how did Anavex account for missing data and dropouts. Data imputation one way may be significant and another way not. We can be sure the data scientists examined the data using multiple imputation methods. Is the significance with modified ITT or MMRM or is it only with protocol completers? If the significance is only with PC, then don't expect a sustained pop. How does the effect compare with rivastigmine (delta 5.5 between placebo and treated at about the same time).