Bet you never saw a trial design page featured in someone's book before! 

QALSODY became the first treatment for genetic amyotrophic lateral sclerosis (ALS) when it received accelerated approval in 2023. This launch was special, not just because of the milestone it marked in the treatment of this deadly disease, but because it was hard fought. The QALSODY trial failed its primary endpoint. But because of the promise shown by a decrease in a disease biomarker, an FDA advisory committee hearing was held where patients and family members told heart wrenching stories and scientists debated the merits of a biomarker vs statistical significance. 

When it finally received approval, Biogen's regulatory team was understandably anxious that our marketing materials be unimpeachable and pass muster at OPDP. So we developed pieces that explained a very complicated trial both thoroughly and plainly, and we were more than honored to deliver them to this population.