Biotech Values

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It's misperception/misunderstanding FDA is stricter than EMA. They have slightly different standards, no submission of data sets required by EMA, thus EMA depended on sponsor analysis while FDA required submission of datasets, thus the ability to analyze data on their own, sometimes they conclude with different risk/benefit profile. In general, EMA is much tougher on single arm trial while more lenient on surrogate end points like PFS. Many FDA approved drugs got rejected by EMA. Recent examples include Folotyn, Istodax, Qsymia, Fanapt, etc.