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NIHNATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE

Regulatory Consulting to Support Advancement of a Divalent siRNA for Prion Disease

Completed
Institution
BROAD INSTITUTE, INC., MA
Principal investigator
Eric Vallabh Minikel
Funding
$98K
Duration
2023–2026
Open portfolio

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Abstract

PROJECT SUMMARY The overarching goal of the parent grant is to file an Investigational New Drug (IND) application with FDA to enable a first in human trial of our PrP-lowering divalent siRNA therapeutic in prion disease. The goal of this administrative supplement is to provide funding for regulatory consultants who can ensure that our IND application is complete, compliant, coherent, and concise. With guidance from individuals with deep knowledge of the FDA review process, we can submit an IND application with the best possible chance of success, hopefully allowing us to bring this promising therapeutic to clinical trials for patients with prion disease.

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NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKEU01sirnapriontrials patientsindind applicationfdadrug indparent grant

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