Replies to post #166535 on Anavex Life Sciences Corp (AVXL)

[Investor2014]

-the 19 left all fit our profile and all have Some type of benefit regardless which dosage they’re on. It’d be nice if they provide some RWE for them

I would expect about 20% having the gene variants leading to reduced response to A2-73. I would also expect some of the remaining 80% to have issues with A2-73 blood concentration.

Unlikely we have more than 5 - 6 strong responders, but perhaps assuming dosing has been optimised some time ago.

Overall I would hope we see reduced decline compared to SOC for the remaining group.

[tradeherpete]

Ariana, and the genome sequencing will spell the end of Amyloid. You don’t need Precision Medicine to tell you a lot of people are going to get Alzheimer’s. If they support and increase the validity of the 32 person trial then the goose is cooked. I hope.

Then;

The glacier will make A. An about face. B. A U turn. C. Slow down. D. Continue on it’s current course. E. The sticky bun table will be abuzz with chatter for about 5 minutes then go back to previous conversations.

Everyone will be envisioning their job for the next 5 years, making adjustments from cancelling vacations to dusting off resumes. Dinner plans may be changed. There will be a few quiet jet rides home as the sense that the time of plenty is coming to an end.

Harald needs to include an optimistic phrase offering hope for successful transitioning from plaque removal to neural massage. Maybe even a slide with a big arrow and directions to the table with applications or an instructional video titled; How to position yourself for the 21st Century Bio Scramble. He needs to realize this is going to depress the sh*t out of everyone.

The rift of pathways will be growing wider towards an approval and the sooner you choose the right path, the less distance you will have to jump before it is too wide for even Evil Kenevil to traverse with a rocket propelled motorcycle. Time for the glacier to make a course correction. And it’s going to hurt.

imo

[Biostockclub]

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,
Bio

[nidan7500]

JJ

If we only get data on the 5 or 6 strong responders. With a few outliers and no data on the rest of the 19. And nothing about the dropouts

I assume we will have data on all patients in the study, if that is 19 great. I also assume if 5 or 6 respond then the remaining pts will be on to further analysis. I expect that is how this process will work. In fact I would amazed if everyone responded similarly in some envelope.

I expect this discovery-analysis process will/may go on and on, but it is all we got and this AD branch will need to be completed. We should expect the PM process to require dispositioning of all people in the trials. So then, in that context the questions are different for me.

-Who will and how will the patients who are strong responders be followed?-Will all other responders be assigned to an inspection/analysis process which evaluates HOW they are different from those who responded and what to do about it.

I hope we understand that this is only the beginning of the PM process being applied to CNS diseases. The value of AVXL in W/S terms (aside from partnerships) should be driven by their control of CNS disease analysis process model as much as by the products sold. IMO, Dr.M. and his team are driven by the CNS homeostasis model, not only one trial.