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PMR and PMC Dates Email, April 24, 2013 - Kcentra

From: Walton, Beth
Sent: Wednesday, April 24, 2013 10:20 AM
To: Walton, Beth
Subject: FW: BLA 125421/0 - PMR and PMC Dates


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From: David.Desris@cslbehring.com [mailto:David.Desris@cslbehring.com]
Sent: Wednesday, April 24, 2013 9:03 AM
To: Jain, Nisha
Subject: Re: BLA 125421/0 - PMR and PMC Dates


Dear Nisha

 

The Kcentra BLA 125421/0 submission dates for the PMR and PMC commitment dates are provided:

 

19 April 2013 - PMR:

 

•         First protocol for FDA review 31 Oct 2013

•         FDA approved protocol 28 Feb 2014

•         Study start within 3 months following FDA approval of protocol

•         Study completion when enrollment for the Kcentra group is completed. The estimated time needed 6 years. Target 1 June 2020

•         Draft study report 8 months following completion of study. Target 28 Feb 2021.

•         Final study report submitted 31 May 2021.

 

11 April 2013 - PMC:

 

•           31 January 2014 – Final protocol submitted to the FDA;

•           31 July 2014 – Study Initiation;

•           31 July 2019 – Final Clinical Study Report submitted to the FDA.