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# FDA Denies Attorney’s Simufilam Petition
- URL: https://www.fdaweb.com/fda-denies-attorneys-simufilam-petition/
- Published: 2022-02-10T12:00:00.000Z
- Updated: 2026-09-14T17:32:13.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151135

FDA has denied petitions submitted by attorney **Jordan Thomas** (Labaton Sucharow) asking the agency to halt two Cassava Sciences trials of its novel Alzheimer’s drug simufilam pending an FDA audit of concerns raised in the petitions. The initial [petition](https://www.fdaweb.com/petition-wants-2-cassava-simufilam-trials-halted/) called on FDA to audit: 

- the publications relied on by Cassava in support of the scientific claims concerning simufilam;
- the IND application for simufilam’s use in Alzheimer’s disease; and
- all clinical biomarker studies of simufilam in Alzheimer’s disease.

The agency [response](https://downloads.regulations.gov/FDA-2021-P-0967-0017/attachment%5F1.pdf?ref=fdaweb.com) says that while FDA takes seriously the issues raised by Thomas, the petition is being denied solely on the grounds that his requests are not the appropriate subject of a citizen petition. “This response does not represent a decision by the agency to take or refrain from taking any action relating to the subject matter of your petitions,” the letter concludes.