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|Project Number||pCODR 10099|
|Indication||Pediatric Acute Lymphoblastic Leukemia (ALL)|
|Funding Request||For the treatment of pediatric patients with Philadelphia chromosome-negative relapsed or refractory B precursor acute lymphoblastic leukemia (ALL)|
|Review Status||Notification to Implement Issued|
|Pre Noc Submission||Yes|
|NOC Date||April 28, 2017|
|Manufacturer||Amgen Canada Inc.|
|Sponsor||Amgen Canada Inc.|
|Submission Date||February 24, 2017|
|Submission Deemed Complete||March 3, 2017|
|Submission Type||New Indication|
|Prioritization Requested||Requested and Not Granted|
|Stakeholder Input Deadline ‡||March 10, 2017|
|Check-point meeting||May 2, 2017|
|pERC Meeting||July 20, 2017|
|Clarification||The Manufacturer had initially advised that Category 2 submission requirements for a pre-NOC submission would not be available to complete the submission for a June pERC meeting date. An updated target date for the pERC meeting had been set by pCODR, based on the anticipated timing of the manufacturer being able to provide these outstanding submission requirements.|
|Initial Recommendation Issued||August 3, 2017|
|Feedback Deadline ‡||August 18, 2017|
|Final Recommendation Issued||August 23, 2017|
|Notification to Implement Issued||September 8, 2017|
‡ Patient Advocacy Groups (or individual patients and caregivers when there is no patient group) and Clinicians who are registered with pCODR are eligible to provide Input and Feedback. Deadlines for Input and Feedback are by the end of the pCODR business day (5P.M. Eastern Time) of the date noted.