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Wednesday, November 18, 2020 10:03:39 AM
Up for grabs how to define whether or not the primary endpoint was met. The market seems to think not, but I think is great and bodes well for the P3 trial.
Consider this. AVXL (we) are on a journey of continuous CNS learning, as such there may be constraints on defining the or any endpoint. That is actually a good thing b/c we are witnessing learning day to day, it a continuously evolving process which is inadvertently constrained by saying we must have an endpoint. We all understand this of course b/c we think we just have to have something to sell or use when done, hence we create things like trials w/criteria to pass/fail. OK, but what if that practice results in a self inflicted constraint. That is the kind of thinking that causes rat holes like the whole amyloid Plaque solution (myth-that went on for 30+ years). We felt obligated to fix a thing we had incompletely understood b/c it fit our mental model of stuff that had to be fixed. This is going to be tough but it has to be done. We have to learn to live with incomplete understanding of what is next or we miss the point. There is no end point. It is continuous, so we better figure out how to define next steps, and live w/that status. Like, maybe we get to Mars some day but, in the meantime...
Stay tuned. Dr. Peter Senge, "The Fifth Discipline" (a brilliant humble guy and an amazing instructor who I had the opportunity to intern w/for 2 years) addresses this point well. He describes 3 levels of knowledge involved in the process of learning. IMO, the AVXL team is at the point where they literally are learning new things every minute. If we are standing there saying..."well, what's the end point and did you make it???". Then IMO, we don't get it. We/they are crossing a knowledge expansion threshold, it is the interface at which learning happens in his model. We are at the point where (Senge defines as) "Understanding what we do not know." This is like changing a flat tire while going 60 MPH.
IMO, there will be a pill or whatever treatment which has street value/use in doing two things. 1. We will have an effective PDD treatment. 2. We will be simultaneously then have a floor to work from while moving on to something even better for which the end point-criteria is not yet imagined or understood. (Hopefully useful human life extension treatment).
So, lets all just hang in until we understand better what we have and do not have. We are dealing w/systems, systems push back when changed so we should be comfortable and expect that , so lets deal with what we have, even if we cannot adequately define what is next.
All just my thoughts. I do understand that we all want to see the next step, so do I.
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