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BioCentury
ARTICLE | Regulation

Stealth’s advisory committee meeting showcases power of patient voice

Barth syndrome advocates showed how tenacious patients can seize their destiny

By Steve Usdin, Washington Editor 
October 14, 2024 11:58 PM UTC

Following a dramatic advisory committee meeting on elamipretide from Stealth BioTherapeutics, FDA finds itself in a familiar, uncomfortable place. Advocates of patients with a devastating ultrarare condition with no approved treatments are demanding that the agency overlook flawed data to approve a drug, while the agency’s reviewers are adamant the data do not support approval.

All parties agree on one thing — it could be impossible to generate conclusive data. ...

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