While a second, confirming trial may be the rule, it is not an EMA requirement. Historically, in fact, there have been plenty of single trial EMA approvals -- 45 percent of new, active substances during one period studied:
While this statistic does not extend to CNS diseases during that period, I think the "not a requirement" point still applies.
I am less convinced than some others here that the Anavex version of CNS trial data is, for purposes of regulatory acceptance, representative of the class of prior CNS drug trials as a whole -- particularly given its unusually safe profile and relatively high efficacy.
There should be a distinction made between what has been customary and what has been required by the EMA. They aren't the same.
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