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|Project Number||pCODR 10085|
|Strength||140 mg Capsule|
|Indication||Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (previously untreated)|
|Funding Request||For patients with previously untreated CLL/SLL for whom fludarabine-based treatment is considered inappropriate|
|Review Status||Notification to Implement Issued|
|Pre Noc Submission||Yes|
|NOC Date||July 19, 2016|
|Manufacturer||Janssen Canada Inc.|
|Sponsor||Janssen Canada Inc.|
|Submission Date||April 20, 2016|
|Submission Deemed Complete||April 27, 2016|
|Submission Type||New Indication|
|Prioritization Requested||Requested and Granted|
|Stakeholder Input Deadline ‡||May 4, 2016|
|Check-point meeting||June 14, 2016|
|pERC Meeting||August 18, 2016|
|Initial Recommendation Issued||September 1, 2016|
|Feedback Deadline ‡||September 16, 2016|
|pERC Reconsideration Meeting||October 20, 2016|
|Final Recommendation Issued||November 3, 2016|
|Notification to Implement Issued||November 18, 2016|
‡ 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.