I see a theme.
There have been two unusual procedural twists in the blarcamesine MAA: First, the CHMP's four weeks heads up on an expected negative CHMP vote that was combined with an invitation to submit biomarker data; and, second, the committee's acceptance of a third party intervention before the initial committee vote (rather than during the re-exam).
Both of these actions demonstrate the CHMP committee's clear desire to be further educated on the science underlying this novel drug.
We are being reminded that a first in class drug application does not stand on the shoulders of predecessors. Instead, it has to beat its own path through an unexplored scientific wilderness. The application has to establish elements that conventional pharmaceuticals can just assert as conventional wisdom. We have always known this in the backs of our minds.
Consequently, there are just a lot of preliminary scientific claims that the EMA will have to evaluate and judge. But it appears to me that the CHMP committee is showing signs of an appetite to do the harder work of approving a potentially groundbreaking drug.
Missling has made scientific research a central component of blarcamesine's trial design and its aftermath. He has advanced the state of the science and built the foundations of a new approach to addressing Alzheimer's. It turns out that these efforts weren't luxuries, but necessities, and we will know shortly if they have been enough for a regulatory approval in Europe.
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