FDA Denies Attorney’s Simufilam Petition

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 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 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.