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Retrospective observational study of patients from open-label extension portion of the TAZPOWER trial compared to the natural history control

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Trial Profile

Retrospective observational study of patients from open-label extension portion of the TAZPOWER trial compared to the natural history control

Status: Completed
Phase of Trial: Phase IV

Latest Information Update: 30 Jun 2022

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At a glance

  • Drugs Elamipretide (Primary)
  • Indications Barth syndrome
  • Focus Registrational; Therapeutic Use

Most Recent Events

  • 14 Jun 2022 According to a Stealth BioTherapeutics media release, the FDA has granted the meeting request and the meeting expects to occur during the third quarter.
  • 14 Jun 2022 According to a Stealth BioTherapeutics media release, the company requested a Type B pre-NDA meeting with the U.S. Food & Drug Administration (FDA) Division of Cardiology and Nephrology (DCN) to discuss new clinical data on patients treated with elamipretide for over 3.5 years in the open-label extension of this trial that may support an NDA filing and approval of elamipretide.
  • 11 Nov 2021 According to a Stealth BioTherapeutics media release, the FDA granted a Type A meeting with DCN to discuss why this trial comparing SPIBA-201 results to a retrospective natural history control and the primary basis for the NDA submission, was not sufficient to support the filing of the NDA. This meeting is scheduled for later this quarter.

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