The US FDA’s decision to reverse a refuse-to-file action on Alkermes PLC’s investigational antidepressant ALKS 5461 is very good news for Alkermes – but it is hard to argue that either the agency or the sponsor comes out of the regulatory kerfuffle looking particularly good.
The decision to refuse-to-file an application is typically based on missing data or facial deficiencies within the submission. In the case of ALKS 5461, there appears to have been a...
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