From the poster overview panel.
"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"
Thinking back to the P2a study outliers with little to no response even when in the therapeutic concentration window of response >= 4ng/mL, perhaps there are several PDD P2 patients that didn't really respond to A2-73 compared to placebo, whereas others did really well.
Perhaps the reason for this can be found in genetic variants not just in the SIGMAR1 gene, but also in the two clusters of genes identified as part of neurodegenerative pathways shared between several CNS diseases.
The highlighted text above suggests to me that the next (pivotal) Parkinson's clinical trials we be true Precision Medicine, in that only patients matching particular genetic profiles will be enrolled to enhance the chances of approval.
The findings and their p-values as described in the poster may well enhance the outcomes measures of those P3 trials to gain approvals.
It remains to be seen how strong the P2b/3 trial readout will be. At this juncture I don't feel this poster has scored a "WGT" level conclusion. Rather, it feels like the readout may be ok, but needs another P3 Precision Medicine trial.
I think we have all been feeling that the time between the PPD readout and any concrete action has been long. It looks like the time has and is being spend in the analysing and thinking box. I suppose we could hear more about the initiation of those trials this year or early 2023.
That would make for 3 expensive yet to be designed clinical trials to include the poster findings and to be initiated. It would take more time and money before that 'year of Anavex!' arrives.
Not feeling more convinced by this poster. We may be back to hoping the EXCELLENCE study and rare diseases may lead to the potential start of Anavex being a revenue company...
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