Replies to post #445003 on Anavex Life Sciences Corp (AVXL)

[mike_dotcom]

Oh wow. The shorts win.

[JKS3]

Now we know that Anavex will not have anything for the next decade except paying Missling well.

[frrol]

The Excellence trial RSBQ results appears similar to the Avatar trial, in that interim responses (at least at week 4) were higher than end-of-study, so if we had used AUC then the endpoint may have been "stat-sig" (like Avatar). But AUC is not an appropriate endpoint gauge for a larger trial, so we dropped it for Excellence and went back to the normal at-week-12 score. It failed for at-week-12, as Avatar likely did. (The company didn't provided data or graphs for Avatar, either. Ah, Missling.) CGI just outright failed, unfortunately.

It looks like the company is correct that drug results (for RSBQ) were clearly positive and just barely not stat-sig, and would have been stat-sig if not for unusually strong placebo results. The company is going to try to explain away the placebo results, but that's a tough row to hoe with regulators. Nevertheless, Rett is a tough indication to study, which is why we as a company tried to improve the RSBQ endpoint's accuracy. Acadia navigated it successfully, even with similar difficulties.

The results do not appear to be an absolute failure, but a very near miss. We may have more Rett testing to do, though it looks like the company's first strategy is to explain away the placebo effects. Definitely worth a try.

[bas2020]

There's that spin job we were waiting for...

[georgejjl]

The Excellence trial was NOT a failure.

“.,,The LS Mean difference (SE) of -4.61 (2.439) points between treated and placebo groups did not reach statistical significance (n=77; p=0.063)… “

This co-primary end point just missed the arbitrary goal of 5%. That is just 6.3% compared to a goal of 5% or 93.7% compared to 95%. That is far from a failure for th EXCELLENCE Phase 2/3 trial.

In the other co-primary endpoint the EXCELLENCE trial met it goal of less than 0.05 this is good.

“…ANAVEX®2-73-treated patients demonstrated a rapid onset of action with improvements at 4 weeks after treatment with a RSBQ total score LS Mean (SE) -10.32 (2.086) points in the drug-treated group compared to a LS Mean (SE) -5.67 (2.413) points in placebo-treated patients. The LS Mean difference of -4.65 (2.233) points between treated and placebo groups was statistically significant (n=77; p=0.041).…”

Read the TLR yourself. This EXCELLENCE trial was far from a failure as is evident by the number of participants requesting to stay on the drug after the trial for the OLE follow on study and even after the OLE for compassionate usage.

This trial and drug, blarcamesine is a success for girls with Rett syndrome!!!

https://www.anavex.com/post/anavex-life-sciences-provides-update-rett-syndrome-program

Good luck and GOD bless,