Stealth’s advisory committee meeting showcases power of patient voice

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. ...