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# Petition Wants 2 Cassava Simufilam Trials Halted
- URL: https://www.fdaweb.com/petition-wants-2-cassava-simufilam-trials-halted/
- Published: 2021-09-01T12:00:00.000Z
- Updated: 2026-09-14T17:12:46.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150054

An 8/18 petition submitted to FDA by attorney **Jordan Thomas** (Labaton Sucharow) asks FDA to halt two ongoing Cassava Sciences trials of its novel Alzheimer’s drug simufilam pending an agency audit of concerns raised in the petition. The [document](https://downloads.regulations.gov/FDA-2021-P-0930-0001/attachment%5F1.pdf?ref=fdaweb.com) says Cassava has publicly announced the completion of a successful end-of-Phase-2 meeting with FDA and has said the company and agency are aligned on key elements of a Phase 3 program that will start this month.

“Information available to the petitioner … raises grave concerns about the quality and integrity of the laboratory-based studies surrounding the drug candidate and supporting the claims for its efficacy,” the petition says. “Petitioner is therefore requesting FDA to halt the clinical studies pending a thorough audit of the publications and data relied on by Cassava in support of its claims.”

The petition calls specifically for FDA to audit **(1)** the publications relied on by Cassava in support of the scientific claims concerning simufilam; **(2)** the IND application for simufilam’s use in Alzheimer’s disease; and **(3)** all clinical biomarker studies of simufilam in Alzheimer’s disease. The petition also asks that FDA oversee third-party reanalysis of all clinical biomarker studies of simufilam in Alzheimer’s disease.