Anavex Life Sciences Corp (AVXL)

[Joseph_K]

There are differing opinions. Anavex did not present the Top-Line Results in a typical way. Some people on this board think that was a serious oddity or failure, others don't. This may be more work than you want to put in, but I ended up reading various of frrol's posts* from about December 4 thru 7, maybe a bit earlier to a bit later. I regard him as one of two notable skeptical longs on this board. If you don't mind the effort, you'll find it worthwhile with respect to your question. You might benefit also from reading a post** by the other skeptical long, Investor2014. (You can see where I was coming from when reading frrol's and Investor's posts by looking at the post linked below. ***)

The trial had three endpoints: ADAS-COG, CDR-SB, and ADCS-ADL. Missling, our CEO, provided the expected, common statistic of mean change over time, for blarcamesine and for the placebo, only for the first and second. To some, not providing this for ADCS-ADL seemed like a glaring omission. He emphasized, for the first and third endpoints, the Odds Ratio statistic, e.g., "ANAVEX®2-73 treatment was 167% [reflecting an Odds Ratio of 2.67] more likely have improve function compared to placebo, at clinically significant ADCS-ADL score change of +3.5 points or better at 48 weeks." Odds Ratio is an uncommon choice for the TLR. (Much less odd if it was stated in the Statistical Analysis Plan prior to the start of the trial, but we don't know that, one way or the other.) Significantly, the provided data does not state how many in the drug arm and how many in the placebo arm had a score change of +3.5 points or better (Investor refers to these numbers as n); that's a weird omission and makes it impossible to determine the significance of the touted Odds Ratio.

Some justifications for these choices in the manner of presenting the data include that the nature of blarcamesine is that there are multiple factors that impact its efficacy, like having the right sigma-1 receptor gene, which APOE gene alleles the subject has, and, since there were low-dose and high-dose arms, which arm the subject was in. So the results aren't Gaussian and the typical way of presenting the data was not suitable. I don't believe there's any thinking person on this board who does not believe the efficacy of the high dose will be be far greater than the low dose, based on the P2 results, and there were time constraints because of a delay by the German CRO that made separating the data for those arms undoable prior to presenting the results at CTAD, as had been promised.

Additionally, Adam Feuerstein, who writes for the biotech magazine Stat, immediately attacked the data release, and he was widely parroted. Much of what he said/says is nonsense, but I think the choice of Odds Radio, along with the opaque way of presenting it, left the company open to attack.

Personally, I believe the issues will be satisfactorily addressed when a peer-reviewed article comes out; Missling has said there will be one, but there's no way for anybody at this point to know when that will be.

I got deeply invested myself in Anavex because of the work on Alzheimer's, but note the plethora of medical indications for which it's being trialed or conceivably may be.

I've been on this message board just one month and I've learned a lot, so I figured I'd welcome you with this one painstaking reply. :) Good luck here!

* https://investorshub.advfn.com/boards/profile.aspx?user=482919&page=8
** https://investorshub.advfn.com/boards/read_msg.aspx?message_id=171251743
*** https://investorshub.advfn.com/boards/read_msg.aspx?message_id=171247274