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|Project Number||pCODR 10060|
|Strength||20mg/mL (100mg vial)|
|Indication||Metastatic Colorectal Cancer|
|Funding Request||For the treatment of patients with WT RAS mCRC in first line treatment setting in combination with FOLFOX|
|Review Status||Notification to Implement Issued|
|Pre Noc Submission||Yes|
|NOC Date||August 31, 2015|
|Manufacturer||Amgen Canada Inc.|
|Sponsor||Amgen Canada Inc.|
|Submission Date||April 15, 2015|
|Submission Deemed Complete||April 22, 2015|
|Submission Type||New Indication|
|Prioritization Requested||Not Requested|
|Stakeholder Input Deadline ‡||April 29, 2015|
|Check-point meeting||July 6, 2015|
|pERC Meeting||September 17, 2015|
|Initial Recommendation Issued||October 1, 2015|
|Feedback Deadline ‡||October 16, 2015|
|pERC Reconsideration Meeting||November 19, 2015|
|Final Recommendation Issued||December 3, 2015|
|Notification to Implement Issued||December 18, 2015|
‡ 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.