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

Award Number: U01NS132994
ORGANIZATION: NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $98,280 )
2025	2025	THE BROAD INSTITUTE, INC	415 MAIN ST	CAMBRIDGE	MA	02142	MIDDLESEX	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	2	12/3/2024	SUPPLEMENT FOR EXPANSION	$98,280
														Subtotal = $98,280

Issue Date FY: 2024 ( Subtotal = $806,536 )
2024	2024	THE BROAD INSTITUTE, INC	415 MAIN ST	CAMBRIDGE	MA	02142	MIDDLESEX	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	2	8/12/2024	NON-COMPETING CONTINUATION	$806,536
														Subtotal = $806,536

Issue Date FY: 2023 ( Subtotal = $800,485 )
2023	2023	BROAD INSTITUTE, INC., THE	415 MAIN ST	CAMBRIDGE	MA	02142	MIDDLESEX	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	1	8/1/2023	NEW	$800,485
														Subtotal = $800,485

Grand Total All Awards = $1,705,301

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

Award Number: U01NS132994

ORGANIZATION: NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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