Biotech Values

[DewDiligence]

YMAB’s Omburtamab rejected by CHMP:

https://www.globenewswire.com/news-release/2022/12/16/2575746/0/en/The-CHMP-has-Adopted-a-Negative-Opinion-for-Omburtamab-for-the-Treatment-of-CNS-LM-Metastasis-from-Neuroblastoma-in-Europe.html

CHMP considered that it was not possible to conclude on the effectiveness of omburtamab as the main study did not have a randomized comparator.

An admonition for those who might think NWBO has an approvable dataset.

YMAB is down only 5% in AH trading; the CHMP’s rejection is hardly surprising given the FDA’s CRL two weeks ago for essentially the same reason (#msg-170587417).