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  5. DDT COA #000129: Advanced Gait Analysis
  1. Drug Development Tool (DDT) Qualification Programs

DDT COA #000129: Advanced Gait Analysis

Clinical Outcome Assessments (COA) Qualification Submissions
Office of Neuroscience (ON)
Division of Neurology I (DN I)

DDT COA Number
DDT COA #000129

Instrument Name
Advanced Gait Analysis

Disease/Condition
Huntington’s Disease

Concept of Interest
Progressive gait abnormality

Context of Use
Ambulatory adults with pathogenic genetic mutation and CAG expansion indicative of HD

COA Type
DHT- Passive Monitoring COA

Qualification Stage
Letter of Intent - Not Accepted

Requestor(s)
MC10, Inc

Contact(s)
Kathryn Nolan

Date Accepted into CDER’s COA Qualification Program
n/a

Submission and Regulatory Correspondence History

Qualification Submission Date FDA Submission Decision & Recommendations Date
Letter of Intent 4/13/20 FDA Response (Not Accepted) 6/5/20
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