Friday, November 19, 2021 12:16:17 PM
I hadn't picked up on the Lewy body misdiagnosis in the PDD trial. I didn't read you post. That was when I had Covid and was not paying attention to a whole lot.
Thanks for re linking it. That is very interesting that Anavex gets a peek at 2-73 treating Lewy body dementia as a by product of the trial.
You make a good case for the complexity of the analysis of the trial data. It appears to me that there is much more information being produced that shows the interrelatedness of the various CNS diseases than was expected when the trial was initiated. That same data may well show that 2-73 is a generalized treatment for CNS rather than the usual specific drug targeted to a specific indication that the FDA is used to. That would support the MOA of restoring homeostasis to the CNS.
If much of the above is true then both the FDA and the company have to decide to choose between the conventional approach to targeting specific indications or adopting a broader view of CNS diseases and a single drug that can positively affect many indications. That represents a paradigm shift in regulation and understanding. I can see why even raising such a question would slow down the data preparation and packaging process. Such a possibility would also necessitate a lot of conversation with the FDA over time as the FDA digested the information and had internal conversations with the various groups that would be involved.
Curiouser and curiouser said Alice.
Thanks for re linking it. That is very interesting that Anavex gets a peek at 2-73 treating Lewy body dementia as a by product of the trial.
You make a good case for the complexity of the analysis of the trial data. It appears to me that there is much more information being produced that shows the interrelatedness of the various CNS diseases than was expected when the trial was initiated. That same data may well show that 2-73 is a generalized treatment for CNS rather than the usual specific drug targeted to a specific indication that the FDA is used to. That would support the MOA of restoring homeostasis to the CNS.
If much of the above is true then both the FDA and the company have to decide to choose between the conventional approach to targeting specific indications or adopting a broader view of CNS diseases and a single drug that can positively affect many indications. That represents a paradigm shift in regulation and understanding. I can see why even raising such a question would slow down the data preparation and packaging process. Such a possibility would also necessitate a lot of conversation with the FDA over time as the FDA digested the information and had internal conversations with the various groups that would be involved.
Curiouser and curiouser said Alice.
If investing was easy, everyone would be rich by now.
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