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Bourbon_on_my_cornflakes

11/18/25 1:48 PM

#508819 RE: Hoskuld #508795

Bureaucratic CYA

"Strange that the missed ADL endpoint was a big deal because that is not an EMA requirement"


one thing that jumped out at me was the CHMP committee appears to be NOT a committee of neurologists, but a committee of various MDs.
Other non-neurologist MDs may not be familiar with the nuances of the tests for early alz, and their relevance.
Hence they default to "failed one of two test endpoints" and CYA.
No MD can criticize that. Safe. Standard procedures.
But maybe there is a neurologist or two on the CHMP who understands the irrelevance of the second endpoint in early alz,
who realizes what a breakthrought a safe oral medicine would be.
A medicine that saves millions from a slow agony of death.
And he or she is fighting to get the CHMP to delay the decision so they can think out of the box, so they can appreciate the ABCLEAR data.
That is what negative trend indicated to me