Eason Lee's questions to Celcuity Inc (CELC) leadership • Q2 2025
Question
Eason Lee of Leerink Partners questioned the use of Blinded Independent Central Review (BICR) for the PFS endpoint, asking if investigator-assessed data would also be presented and about the typical concordance between the two methods as viewed by regulators.
Answer
CEO Brian Sullivan clarified that BICR is the FDA-recommended method for open-label studies like VICTORIA-1 to eliminate potential investigator bias. He noted that investigator-assessed data is exploratory and will be presented later. He expressed high confidence in the data, citing studies showing high concordance (over 95%) between BICR and investigator assessments and confirming that sensitivity analyses prescribed by the FDA show the data is robust.