Status: At riskRARE-007
Sponsor viewShared with Northwind Genetics
Northwind Genetics
RARE-007 · X-linked hypophosphatemia in adults
Phase 3EnrollingRare diseaseAt risk
Executive summary
Pivotal Ph3 placebo-controlled study. Enrolment is critically behind (41% vs 65% planned) and a Type B FDA meeting is scheduled to discuss sample-size re-estimation. EAC has breached the contracted budget.
Phase
Phase 3
Stage
Enrolling
Health
At risk
Milestone timeline
Showing completed, in-progress, and at-risk milestones. Planned future milestones are omitted from the sponsor view.
Mar 1, 2024forecast end Aug 30, 2028
- Complete
FPI
Apr 18, 2024
- In progress
50% enrolment
Dec 15, 2025
- At risk
75% enrolment
Aug 20, 2026
- At risk
LPI
Feb 15, 2027
Signed deliverables
Updated live as deliverables are signed.
- Essential Documentsfiled and signed
- Audit Trailgreen
- CSR draftnot yet released to sponsor
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