JFais
$MREO $RARE
Q3 call nuggets on setrusumab in OI:
"R&D spend includes filings and things to support filings for approval" (interesting wording 🤔)
Clinically meaningful reduction in fractures for both ORBIT and COSMIC studies in patients with greater than 3 fractures
There is great demand from patients to stay on drug
Biomarker data on BMD is profound and large, supportive data for pain and physical function,
Combined with reduction in high fracture population, "there is a valuable product we are pursuing"
Have to resolve how much data is required and the best way to move it forward
If they run a confirmatory study (theoretical analyst question), would choose higher PoS population (ie. younger patients that respond more consistently and had higher frequency to begin with, but think the drug works in all patients)
Appreciate the FDA working with them through this, don't have an answer yet
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