Greg Wiessner

Greg Wiessner, on for Tyler Van Buren, asked for any early indications of demand for COVID-19 vaccines for the upcoming fall and winter season based on customer interactions.

Answer

President Stephen Hoge noted that international demand is stable due to advanced purchase agreements. In the U.S., he described the spring booster campaign as 'solid,' with uptake in the 65+ population down only 1-2%. While these are encouraging signs and customers are preparing, he stated the company remains 'cautiously optimistic' as the true demand picture will emerge in September.

Greg Wiesner from TD Cowen requested insight into what Travere plans to propose during its Type C meeting with the FDA for sparsentan in FSGS and what key questions the company intends to ask the agency.

Answer

SVP of Research and Development Dr. Bill Rote explained that the company will leverage discussions from the PARASOL initiative and propose a proteinuria reduction threshold, likely around the 0.7 gram/gram/day level the FDA has mentioned. The key question for the FDA will be to clarify what additional data or analyses are needed for the submission to ensure full alignment for their review.