Biotech Values

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But the EMEA does sometimes seem to be "easier"

The key words are SOMETIMES, and SEEMS. Sometimes EMA are tougher. EMA generally prefer comparators, for example, Carfilzomib, EMA wouldn't entertain ONXX's filing based on single arm trial in rrMM. In addition, several drugs FDA refused to approve while EMA approved had to be withdrawn later on, for example, SNY'S Acomplia.