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).
“The efficient-market hypothesis may be the foremost piece of B.S. ever promulgated in any area of human knowledge!”
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