Too Big To Succeed? Cytokinetics Heart Failure Trial Proves Too Much For FDA Committee

 
• By Michael McCaughan

US FDA asked a very typical question of its advisory committee about Cytokinetics’ omecamtiv mecarbil: is there ‘substantial evidence’ of efficacy? But in this case the issue wasn’t a trial that was too small or clearly flawed – it was whether such a large, rigorous trial should have shown more than it did.

to big to succeed
Cytokinetics couldn’t leverage its large, successful trial for omecamtiv mecarbil into a positive vote at a FDA advisory committee. • Source: Shutterstock

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