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Pivotal single-dose bioavailability study of CCP-07

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Trial Profile

Pivotal single-dose bioavailability study of CCP-07

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 21 Apr 2017

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At a glance

  • Drugs TRN 124 (Primary)
  • Indications Common cold
  • Focus Pharmacokinetics

Most Recent Events

  • 21 Apr 2017 According to a Vernalis media release, the US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for CCP-07. The CRL did not raise any concerns with the formulation or pharmacokinetic profile of CCP-07 but did identify outstanding items that need to be addressed prior to the resubmission and approval of the NDA. The company will be working closely with the FDA to resubmit the NDA as quickly as possible.
  • 01 Dec 2016 According to a Vernalis media release, is filing NDA with FDA with a PDUFA date of 20 April 2017.
  • 23 Dec 2015 New trial record

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