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|Project Number||pCODR 10121|
|Generic Name||Inotuzumab Ozogamicin|
|Indication||Acute Lymphoblastic Leukemia (ALL)|
|Funding Request||For the treatment of relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL)|
|Review Status||Notification to Implement Issued|
|Pre Noc Submission||Yes|
|NOC Date||March 15, 2018|
|Manufacturer||Pfizer Canada Inc.|
|Sponsor||Pfizer Canada Inc.|
|Submission Date||November 13, 2017|
|Submission Deemed Complete||November 20, 2017|
|Submission Type||New Drug|
|Prioritization Requested||Not Requested|
|Stakeholder Input Deadline ‡||November 27, 2017|
|Check-point meeting||January 25, 2018|
|pERC Meeting||April 19, 2018|
|Initial Recommendation Issued||May 3, 2018|
|Feedback Deadline ‡||May 17, 2018|
|pERC Reconsideration Meeting||June 21, 2018|
|Final Recommendation Issued||July 6, 2018|
|Notification to Implement Issued||July 23, 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.