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Prevention of Vascular Complications by BetaBlocker Treatment in Vascular Ehlers-Danlos Syndrome

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Trial Profile

Prevention of Vascular Complications by BetaBlocker Treatment in Vascular Ehlers-Danlos Syndrome

Status: Discontinued
Phase of Trial: Phase IV

Latest Information Update: 20 Mar 2020

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At a glance

  • Drugs Celiprolol (Primary)
  • Indications Ehlers-Danlos syndrome
  • Focus Registrational; Therapeutic Use
  • Acronyms BBEST trial

Most Recent Events

  • 18 Mar 2020 According to an Howard G. Smith media release, the Office of New Drugs (OND) of the U.S. FDA has denied Acer appeal of the CRL in relation to the NDA for EDSIVO. In its Appeal Denied letter, the OND describes possible paths forward for Acer to explore that could provide the substantial evidence of effectiveness needed to support a potential resubmission of the EDSIVO NDA for the treatment of patients with vascular Ehlers-Danlos syndrome (vEDS) with a confirmed COL3A1 mutation.
  • 13 Nov 2019 According to an Acer Therapeutics media release, the company conducted a Type A meeting in October 2019 with the U.S. Food and Drug Administration (FDA) regarding the EDSIVO™CRL and engaged with industry experts to determine an optimal path forward. The company expects evaluating an appeal via Formal Dispute Resolution Request (FDRR) to the Office of New Drugs (OND) with potential submission by the end of 2019.
  • 13 Aug 2019 According to an Acer Therapeutics media release, the company plans to conduct Type A meeting with FDA in Q3 2019 to discuss EDSIVO Complete Response Letter.

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