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|Project Number||pCODR 10204|
|Indication||Minimal Residual Disease (MRD)-Positive B-Cell Precursor Acute Lymphoblastic Leukemia (BCP ALL)|
|Funding Request||Patients with Philadelphia chromosome-negative CD19 positive B-precursor acute lymphoblastic leukemia (ALL) in first or second hematologic complete remission with minimal residual disease (MRD) greater than or equal to 0.1%|
|Review Status||Notification to Implement Issued|
|Pre Noc Submission||No|
|NOC Date||December 19, 2019|
|Manufacturer||Amgen Canada Inc|
|Sponsor||Amgen Canada Inc|
|Submission Date||January 20, 2020|
|Submission Deemed Complete||February 3, 2020|
|Submission Type||New Indication|
|Stakeholder Input Deadline ‡||February 3, 2020|
|Check-point meeting||April 9, 2020|
|pERC Meeting||August 20, 2020|
|Initial Recommendation Issued||September 3, 2020|
|Feedback Deadline ‡||September 18, 2020|
|pERC Reconsideration Meeting||October 15, 2020|
|Final Recommendation Issued||October 29, 2020|
|Notification to Implement Issued||November 13, 2020|
‡ 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.