No official orders from Judge Marston regarding the bellwether process set by the late Judge Pratter had been filed as of June 11, but we think Marston is likely to continue the work of the late judge and work with attorneys to choose cases for bellwether test trials and coordinate discovery proceedings
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The NDA submission was partly based on topline results from the ongoing single location BHV4157-206-RWE study (NCT06529146), in which troriluzole 200 mg administered orally once daily led to a 5070% slower rate of decline from baseline in the functional Scale for the Assessment and Rating of Ataxia (f-SARA) in all SCA genotypes at 3 years compared to an external control arm. Data from the BHV4157-206 study (NCT03701399) also demonstrated disease stabilization in the SCA3 genotype and a reduction in falls in all SCA genotypes compared to placebo over 48 weeks. If approved, troriluzole will be the first and only medication indicated for the treatment of SCA
150 mg Other Ingredients: Vegetarian capsule (hydroxypropyl methylcellulose, water) and ascorbyl palmitate