Replies to post #241871 on Biotech Values

[DewDiligence]

YMAB—ODAC votes 16-0 against 131I-omburtamab:

https://www.yahoo.com/now/y-mabs-announces-outcome-fda-193300494.html

Y-mAbs Therapeutics…today announced the outcome of the meeting of the U.S. Food and Drug Administration (“FDA”) Oncologic Drugs Advisory Committee (“ODAC”), which reviewed investigational 131I-omburtamab (“omburtamab”) for the treatment of CNS/leptomeningeal metastasis from neuroblastoma. The committee voted 16 to 0 that the Company had not provided sufficient evidence to conclude that omburtamab improves overall survival.

The BLA is based a single-arm trial with an external (historical) control, which can make efficacy difficult to measure.

The stock is currently halted.