We need another “Citizens Petition” to FDA for Simufilam Accelerated Approval !

This petition for administrative action is submitted on behalf of the undersigned Petitioner pursuant to 21 C.F.R. § 10.30 and related relevant provisions of the Federal Food, Drug, and Cosmetic Act or the Public Health Service Act to request that the Commissioner of Food and Drugs (the "Commissioner") consider accelerated approval of the drug Simufilam (formerly PTI-125) sponsored by Cassava Sciences (NCT04388254 and NCT04994483), pending a thorough audit by the FDA of the matters described herein. Cassava Sciences is a public company that is focused on developing therapies targeted at Alzheimer's Disease. Cassava is currently sponsoring clinical trials NCT04388254 and NCT04994483 for its proprietary drug Simufilam, which is claimed to represent a novel approach to Alzheimer's treatment. In its recent SEC filings and elsewhere, the company has publicly announced the successful completion of its End of Phase 2 meeting for Simufilarn with the FDA, and stated that the company and the FDA are aligned on key elements of a Phase 3 clinical program. The company has stated that it expects to initiate its Phase 3 program with Simufilam in September 2021. Cassava Sciences Announced Top-line Results of 12-month Interim Analysis from Open-label Study Evaluating Simufilam in Alzheimer’s Disease

Petitioner is therefore requesting the FDA for earlier approval of Simufilarn considering positive research and trial data. This medicine fill an unmet medical need to treat Alzheimer's disease.$Cassava Sciences Inc(SAVA)$

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