Jan. 13 at 11:26 PM
This one is a clever bit of spin, but it completely ignores how the FDA actually thinks. The argument is essentially: "FDA likes clinical outcomes, so
$GALT wins because varices > biomarkers."
WRONG.
The FDA approved Resmetirom (
$MDGL) not because they prefer biomarkers, but because the data was bulletproof in the ITT population (p<0.001). Belapectin failed the gold standard: the primary clinical endpoint in the full ITT group. You cannot rescue a failed trial by cherry picking the Per-Protocol (PP) subgroup, that is textbook selection bias, and regulators are trained to reject it.
The FDA will take robust, statistically significant biomarker data over shaky, post-hoc clinical claims every day of the week. You don't get credit for targeting a "real outcome" if you miss the p-value.
