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

Trial Profile

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

Status: Discontinued
Phase of Trial: Phase IV

Latest Information Update: 13 Nov 2019

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At a glance

  • Drugs Celiprolol (Primary)
  • Indications Ehlers-Danlos syndrome
  • Focus Registrational; Therapeutic Use
  • Most Recent Events

    • 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.
    • 12 Jul 2019 According to an Howard G. Smith media release, Specifically, Acer failed to disclose to investors: (1) Acer lacked sufficient data to support filing EDSIVO's NDA with the FDA for the treatment of vEDS; (2) the Ong Trial was an inadequate and ill-controlled clinical study by FDA standards, and was comprised of an insufficiently small group size to support EDSIVO's NDA; (3) consequently, the FDA would likely reject EDSIVO's NDA; and (4) that, as a result of the foregoing.
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