[Trial Data] phase 2 biopsy endpoints, and what "resolution" means
Thinking out loud about this: phase 2 biopsy endpoints, and what "resolution" means. The honest evidence position, written out so this board does not drift. Phase 2 data exists in a specific, biopsy-characterised population, with a slow protocol escalation and tolerability tables worth reading in full. Nothing…
Yes — nothing containing this is approved anywhere, which is the first fact and usually the last one mentioned.
not approved anywhere, and the boards forget that constantly
not approved anywhere, and the boards forget that constantly
dario_boateng is right that biopsy and imaging endpoints are not interchangeable.
I would not read across from the obesity programmes. Different population, different endpoint, different question.
How fast was the escalation in that protocol?
That figure is from the obesity programme, and this thread is about the hepatic one.
That figure is from the obesity programme, and this thread is about the hepatic one.
Agreed — and the endpoint definitions are where the actual claim lives.