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|Project Number||pCODR 10044|
|Indication||First Line Metastatic Castration-Resistant Prostate Cancer|
|Funding Request||Treatment of patients with metastatic castration-resistant prostrate cancer (mCRPC) who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy who have not received prior chemotherapy|
|Review Status||Notification to Implement Issued|
|Pre Noc Submission||Yes|
|NOC Date||April 15, 2015|
|Manufacturer||Astellas Pharma Canada, Inc.|
|Sponsor||Astellas Pharma Canada, Inc.|
|Submission Date||October 2, 2014|
|Submission Deemed Complete||October 9, 2014|
|Submission Type||New Indication|
|Prioritization Requested||Requested and Not Granted|
|Stakeholder Input Deadline ‡||October 17, 2014|
|Check-point meeting||February 2, 2015|
|pERC Meeting||May 21, 2015|
|Clarification||The Manufacturer had advised that Category 2 submission requirements for a pre-NOC submission were not available to complete the submission for an April 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. A confirmed pERC meeting date is posted as all pre-NOC submission requirements have been met.|
|Initial Recommendation Issued||June 4, 2015|
|Feedback Deadline ‡||June 18, 2015|
|Final Recommendation Issued||June 22, 2015|
|Notification to Implement Issued||July 8, 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.