SUBSEQUENT EVENTS

9 Months Ended

Sep. 30, 2022

SUBSEQUENT EVENTS

SUBSEQUENT EVENTS

NOTE 16 — Subsequent Event

The Company resubmitted its Biologics License Application (“BLA”), to the FDA for radiolabeled 131I omburtamab for central nervous system, leptomeningeal metastases from neuroblastoma in March 2022 and in May 2022, the FDA accepted our BLA for priority review. The FDA set an action date of November 30, 2022 under the Prescription Drug User Fee Act (“PDUFA”), and convened a meeting of its Oncologic Drugs Advisory Committee (the “Advisory Committee”), on October 28, 2022. The Advisory Committee voted 16 to 0 that the BLA did not provide sufficient evidence to conclude that omburtamab improves overall survival among the target patient population. The FDA is not bound by the Advisory Committee’s recommendations but generally takes the recommendation into consideration when making its decision, and the Company can provide no assurance that omburtamab will ultimately receive FDA approval.