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BrainStorm filed the BLA using the FDAs File Over Protest procedure after the regulator issued a Refuse to File letter in November 2022

revealed that anesthesia and surgery activate NLRP3 inflammatory vesicle caspase-1-dependent pyroptosis and that SS-31 not only exerts protective effects against mitochondrial dysfunction, but also attenuates surgery-induced pyroptosis [96]

However, no effect of selenium supplementation on thyroid stimulating hormone, health-related quality of life or thyroid ultrasound was found in levothyroxine substitution-untreated individuals, and sporadic evaluation of clinically relevant outcomes in levothyroxine substitution-treated patients (108.5)

For some patients that means a simple oral approach

Elevated ceramides are also known to promote apoptosis (Siskind et al., 2010)