Anavex Life Sciences Corp (AVXL)

[Investor2014]

I actually don’t have an explanation to the bizarre ability of Anavex to declare all endpoints met without the ability to present the outstanding data points.

We seem to agree that Anavex must be very sure about their statement and SEC filing regarding meeting all endpoints.

The risk associated with that claim not being factual is untenable, which just highlights how bizarre the situation is.

I don’t think your explanation is a fit. It would mean Anavex making assumptions that overlooks and compensates for whatever defect might be in CRO data.

Whatever calculations were performed, that takes into account some defect and corrects for them to produce the all endpoints met result could have also been used to show the missing results without even revealing said data defect.

After all at this stage TLR/TLD doesn’t require discrete patient data points to be revealed. The full detailed data becomes relevant only for the Clinical Study Report stage before submission to regulatory agencies.

At that point the data and it’s conclusions must be solid, to avoid the risk of regulators later revealing issues rendering the claim to have met all endpoints incorrect.

As a reminder all that would have been required for a solid readout was ADCS-ADL mean change and p-values as well as the n for each Odds Ratio along with clarification of SAP and the use of 1 vs 2 sided tests.

I guess PW is right all we can do is wait to see what if any explanation eventually emerges. Meanwhile, the situation remains bizarre.