Replies to post #368271 on Anavex Life Sciences Corp (AVXL)

[Jonjones325]

"Full genomic analysis of ANAVEX®2-73-PDD-001 Phase 2 study in
patients with Parkinson’s Disease Dementia (PDD) assessed biomarkers
of response exploring potential for a Precision Medicine approach"

Not sure how this statement leads you to believe another P3 for Alz may be required. Isn’t it enough to have our one decent sized trial beat the SOC with biomarkers and gene upregulation proof of our MOA? If anything it seems to strengthen our case for a P4 rather than another P3.

I may agree with another P3 if we didn’t have the outstanding safety profile

On another note, this publication coupled with our educational videos make a perfect set up to release the PDD OLE data.

It shows we are on the right track, hitting targets that are confirming our results.

Hopefully Missling capitalizes on this momentum and raises fund’s opportunistically just in case.

This publication IMO allows us to move forward with the Fragile X and other undisclosed trial and may be the piece they have been waiting for.

[TempePhil]

The poster shows increasing correlation between ALz and Pd, in particular between patients treated with A2-73. That is good for Anavex as the good PD/PDD data points to good results for the ALz trial.

In terms of the 'another trial needed', that keeps coming up here, but I thought I read an article saying that is not true. Also, it does not make sense to design a trial, with FDA input and acceptance, then with positive results, the FDA says OK very good but we dont believe it, do it again, then maybe we will believe it...or maybe you will have to run it again and again... !!?? Does not make sense.

I dont share your pessimism. All trials have had good outcomes. Some, rightly say, there were only 2 super responders in the original ALz trial, but one must understand the 'binning' or subgrouping of the data there, to understand what percentage of the general population of Alz patients that represents. There are probably 100s of people that have now been through the Alz OLE trial, so Dr.M probably has all kinds of data refining the original Alz data. Time will tell.

[frrol]

The company wants to be able to explain or 'contextualize' responders vs non-responders to 2-73. This helps validate efficacy signal (if any). Disease stage, drug plasma levels, S1 type, S1 mRNA levels, and now potentially some of these genes' activations. (This list is in rough order of the MOA stream.)

It could be valuable. Or not. Foremost, we need reliable efficacy signal in large, controlled trials. Watch for trial results.

[crescentmotor]

Not feeling more convinced by this poster.

Same with me. The poster is hard evidence that 2-73 is still very much an exploratory treatment. But...it is possible for the Alzheimer's trial to be stat sig even if the reasons have yet to be fully understood. My opinion still remains that this is a 50-50 shot on goal so I lack the extreme confidence expressed by many board posters. We'll know the answer very soon.

[raja48185]

Anavex has to show in their AD data that the poster conveys the right message with no scope for any doubts.

More waiting.

PDD is going nowhere and we have to wait for the FDA meeting for the next steps.

More waiting

EXCELLENCE Trial data not going to be available until next year

More waiting.