Page 126 - Binder2

But tolerization doesn’t show up in the first 12 weeks.
It shows up in month six. Or nine. Or year two.
It emerges after repeated exposure, in the complex terrain
of real-world immunity—not in the curated timelines of a
Phase III protocol.

And so, if immune durability is the outcome we care about,
our trials must evolve.
We can’t expect long-term compatibility from short-term
study designs.

Here’s how the system needs to change—scientifically,
operationally, and structurally.

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