Jan. 4 at 12:18 PM
ALL 11 PARTS OF THIS STORY GENERATED ON/BY A.I.
$MREO $RARE PART 11 Final
Craft a package that foregrounds the magnitude and consistency of the BMD effect across ORBIT/COSMIC.
Systematically dissect the placebo fracture anomaly and supportive earlier fracture data.
Propose either: (a) an approval based mainly on BMD plus confirmatory commitments, or (b) a smaller, smarter follow‑on study using BMD as primary with enriched high‑risk OI populations.
Net-net, the evolving regulatory acceptance of BMD as a surrogate and FDA’s demonstrated willingness to approve on BMD in analogous bone‑fragility settings materially improves the backdrop for any rescue or re‑positioning strategy RARE’s CMO takes into FDA for ORBIT/COSMIC.
