Simpler Grants.gov #RFA-NS-26-001

NIH Forecasted Funding for ALS Expanded Access Clinical Trial Research

This opportunity is a forecasted funding announcement from the National Institutes of Health (NIH), specifically the National Institute of Neurological Disorders and Stroke (NINDS) and the Office of the Director, for ALS expanded access clinical trial research. - Government Buyer: - National Institutes of Health (NIH) - National Institute of Neurological Disorders and Stroke (NINDS) - Office of the Director - Purpose and Scope: - Funding research using data from expanded access (EA) to investigational drugs or biological products for ALS patients not eligible for ongoing clinical trials - Focus on intermediate size populations - Research protocols should support prevention, diagnosis, mitigation, treatment, or cure of ALS - Funding Details: - Estimated total funding: $40,000,000 - Four expected awards - Cooperative agreement (U01 mechanism) - No cost sharing or matching required - Eligibility: - Clinical trial sites participating in phase 2/3 or phase 3 efficacy trials with FDA-designated sponsors under IND section 505(i) - Products/Services Requested: - No specific OEMs, vendors, products, or part numbers are mentioned - Main service is research utilizing expanded access data for ALS - Unique Requirements: - Research must use data from expanded access protocols for investigational drugs or biological products - Focus on ALS patients not eligible for ongoing clinical trials - No administrative or procedural requirements highlighted - Place of Performance: - National Institutes of Health (NIH)

Description

This opportunity is a forecasted funding initiative by the NIH to support research utilizing data from expanded access for investigational drugs or biological products for ALS patients. The focus is on intermediate size populations of ALS patients not eligible for ongoing clinical trials. The funding is through a cooperative agreement with an estimated total of $40 million and 4 awards. Applications are not being solicited at this time, but the NOFO allows potential applicants to prepare.

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