Replies to post #412320 on Anavex Life Sciences Corp (AVXL)

[crescentmotor]

I suspect that after the initial enrollment for the OLE the loss of participants was a steady decline over time rather than a sudden withdrawal at one time.

That's a fair point to consider. I would still make the case that the ultimate drastic decline in the number of patients was an event that should have been disclosed. Another point: the fact that this was an OLE may also have been a factor that was considered.

[Doc328]

I took another look at the PR.

https://www.anavex.com/post/anavex-2-73-blarcamesine-shows-clinical-benefit-in-long-term-48week-phase-2-extension-study-in-pdd

The OLE enrollment was n= 33-37 and at 24 weeks, there was n=24 and at 48 weeks n=20. Since the OLE was over a long time ago, Missling has known the n values x 2 years. We know there were n=118 patients that were eligible to be in the OLE (successfully completed the 14 week study). So the rollover rate was poor at 27-31% (were these patients representative of the n=118 population or more self selected) and then 35-40% of these dropped out for side effect or perceived lack of efficacy. The n=33 to 37 at baseline for the OLE is perplexing, two people can count these on their fingers and toes so why the variability --- and what effect did using 33 instead of 37 patients entering the trial have on baseline values and stats? An incomplete baseline visit is hard to imagine at any competent site. The n=37 was for the sleep survey that could be done over the phone but MDSUPDRS, CGI and MoCA must be in person. Why such a big dropout rate of 40% --- what would be the effect on the demographics (would be strange if the average patient finished the study younger than the average patient at baseline a year earlier) and in turn the effect on the average scores. Did sicker patients, older patients, more demented patients drop out more than healthier ones? We don't know because the PR has few details.