Great questions and thinking ahead, Jj.
Here is the title of our abstract:
Longitudinal 148-Week Extension Study for ANAVEX®2-73 Phase 2a Alzheimer’s Disease Demonstrates Maintained Activities of Daily Living Score (ADCS-ADL) and Reduced Cognitive Decline (MMSE) for Patient Cohort on Higher Drug Concentration and Confirms Role of Patient Selection Biomarkers
Please note that it stipulates the extension demonstrates maintained scores for ADCS-ADL and reduced cognitive decline based on MMSE “for Patient Cohort on Higher Drug Concentration and Confirms Role of Patient Selection Biomarkers.”
I think I would taper my expectations to include only the higher dosed patients which correlate with higher drug concentrations, which we determined were the bulk of our strong responders and were labeled outliers, and I would not expect all 19 or remaining patients to be included in the maintained test scores and reduced cognitive decline. That’s just my interpretation.
As to whether the performance of the non-high concentrations (all but the strong responders) performed better than SOC, that would certainly matter but is not included in the title.
The part which I believe will be confirmatory as opposed to ho hum, is that there will be an explanation of how the high concentration response confirms the role of patient selection biomarkers.
I think with only 15 mins to present, this will be key and it accounts for why 4 Ariana representatives will be present (not all to speak) as well as why Federico Goodsaid, Regulatory Pathfinders will be there. There must be something conclusive about the biomarkers in the small population of high concentration responders which is sufficiently compelling to believe that a pathway to regulatory approval exists using these biomarkers for patient selection or I don’t think we will have much to discuss as you suggest.
Not knowing exactly what we have and will present which is persuasive enough to make our case, I have faith that our CEO and the contracted specialists have this information as our CEO clearly knows what’s at stake. Also, Dr. Hampel, who will be speaking believes that the evidence is significant enough to be representative of a precision medicine paradigm - that’s his field. He would not put his reputation on the line to rehash something as trivial as 5 or 6 strong responders with no meaningful path forward gleaned from their correlations.
I am resisting the urge at this moment to state what expectations I have which will confirm we have necessary data to a clear victory. Abundance of caution. Additionally, abundance of rodeos...I often learn that there is more work which we have conducted that I am completely unaware of until it is presented and I can’t predict what that will be. However, I can say that I am encouraged that our presentation is late breaking, because if it contained the same info as we have seen with nothing new, it could have been scheduled outside the late breaking category. (Even if it’s just the timing metric that our patients had to reach this point so the results couldn’t have been scheduled earlier, I still believe that if they did not show anything new, we would not risk presenting late breaking “old news” with highly credentialed HH, and Ariana, and Federico Goodsaid, and our CEO, putting their stamps on this.)
Sorry if this is not specific enough to answer the question - it boils down to I’m waiting to see what they present, without setting expectations other than that it will be meaningful and should answer more questions than it evokes. I’m expecting a surprise hit - not a surprise flop. Just not sure what that will be at the moment.
The suspense should be worth it,
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