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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.

FPI — Complete (2024-04-18)50% enrolment — In progress (2025-12-15)75% enrolment — At risk (2026-08-20)LPI — At risk (2027-02-15)
Mar 1, 2024forecast end Aug 30, 2028
  • FPI

    Apr 18, 2024

    Complete
  • 50% enrolment

    Dec 15, 2025

    In progress
  • 75% enrolment

    Aug 20, 2026

    At risk
  • LPI

    Feb 15, 2027

    At risk

Signed deliverables

Updated live as deliverables are signed.

  • Essential Documents
    filed and signed
  • Audit Trail
    green
  • CSR draft
    not yet released to sponsor

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