Replies to post #440461 on Anavex Life Sciences Corp (AVXL)

[abew4me]

Got it. Thanks for clarifying.

[Doc328]

Steady, I do not think there was a serious adverse event in the Rett trial. I think Dr. Missling knows that this readout is taking longer than it should and far longer than Street expectation (which would have been in September or October) and of course even longer than his expectation (2H). He is trying to use a poorly understood aspect of the research protocol to make an excuse for why top line data will not be out the second half of 2023 despite him repeating that expectation multiple times.

Soumit Roy
I see. And one last question on the Rett program. Could you give us a little color, when are you still expecting the data? Is it going to be before the year end 2023? And is there any delay or is it an expected safety window that you have follow-up that you have to -- you are doing which is why pushing the data back.

Christopher Missling
Yes, after the last 12-week readout, there was an additional safety follow-up and that's basically why the timing is maybe a little bit different from expectations, but we are on track to release this data once we have it.

The "maybe a little bit different from expectations" quote is classic Missling - he is the one who set the 2H2023 expectation


Practically every study will have a final safety visit 14 or 30 days after the final treatment visit. This is done for several reasons including to get additional safety information and to make sure that there is not a rebound withdrawal effect (where symptoms may become even worse than baseline when the drug is withdrawn). I actually mentioned this a few times with a couple of the other studies and this trial over the last few years when i discussed a timeline for expected (at least when I expected) results.

To show that this is nothing unique, this is a link to the study protocol for the trofinetide phase 3 study. Despite Acadia having a 30-day safety visit they had no trouble getting results out by expected timelines. Look at the schedule of events page 20 and details p. 42.

I think this also answers comments from jonjones and crescent.

Though I am not worried about there being an unknown expected severe safety issue, I am concerned that the delays in reporting the top line data, likely into 2024, is due to creative statistical analysis (AKA cherry picking)