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Real-World Evidence Fails Another Test At US FDA

 
• By Michael McCaughan

Correvio’s attempt to move vernakalant from 'clinical hold' to 'FDA approved' was a huge long shot. But the advisory committee vote – and looming FDA rejection – are another indication that real-world data is not a panacea.

Business strategy failure as a despair metaphor or financial market drop and psychological burnout symbol in a 3D illustration style.

The main takeaway from Correvio Pharma Corp.’s attempt to revive the cardioversion agent vernakalant in the US is probably that it is not a good idea to try to go straight from “clinical hold” to “NDA approved” status.

After all, the drug has been on clinical hold since 2010 following a patient death after the application had been turned down by the US Food & Drug Administration over...

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