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|Project Number||pCODR 10105|
|Strength||10mg, 50 mg & 100mg tablet|
|Indication||Chronic Lymphocytic Leukemia|
|Funding Request||As monotherapy for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy and who have failed a B-Cell Receptor Inhibitor (BCRi)|
|Review Status||Notification to Implement Issued|
|Pre Noc Submission||No|
|NOC Date||September 30, 2016|
|Submission Date||July 10, 2017|
|Submission Deemed Complete||July 17, 2017|
|Submission Type||New Indication|
|Prioritization Requested||Requested and Granted|
|Stakeholder Input Deadline ‡||July 24, 2017|
|Check-point meeting||September 7, 2017|
|pERC Meeting||November 16, 2017|
|Initial Recommendation Issued||November 30, 2017|
|Feedback Deadline ‡||December 14, 2017|
|pERC Reconsideration Meeting||February 15, 2018|
|Final Recommendation Issued||March 2, 2018|
|Notification to Implement Issued||March 19, 2018|
‡ 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.