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Alkermes CEO on Nuts and Bolts

Love Me Two Times: How SPCD Gets More from Trial Subjects

By Randy Osborne
Staff Writer

Thursday, October 10, 2013

Alkermes plc’s just-won fast-track status for its depression drug, Alks 5461 – along with the willingness of the FDA to let the company skip the end-of-Phase II meeting and move directly into Phase III, as outlined in the firm’s briefing documents – have brought the pivotal trial’s design into the spotlight.

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