Ryan Deschner's questions to PALVELLA THERAPEUTICS (PVLA) leadership • Q2 2025
Question
Ryan Deschner of Raymond James Financial inquired about the target age range for the MLM label, the age distribution of patients enrolled in the CELVA trial, and whether the trial's over-enrollment was more a reflection of high demand or easier-than-expected patient identification.
Answer
President and CEO Wes Kaupinen explained that the CELVA trial enrolls patients aged three and up, but the primary analysis for the label will focus on the six-and-older cohort, with potential label expansion to younger patients pending data. He attributed the over-enrollment to a combination of high demand, effective patient identification, and the strong execution of Palvella's internal clinical operations team.