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).