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|Project Number||pCODR 10207|
|Indication||Acute Myeloid Leukemia (AML)|
|Funding Request||In combination with low-dose cytarabine, for the treatment of newly diagnosed and previously untreated acute myeloid leukemia (AML) in adult patients, who are age ≥75 years or who are not eligible to receive intensive induction chemotherapy.|
|Review Status||Under Review|
|Pre Noc Submission||Yes|
|Manufacturer||Pfizer Canada ULC|
|Sponsor||Pfizer Canada ULC|
|Submission Date||May 6, 2020|
|Submission Deemed Complete||June 18, 2020|
|Submission Type||New Drug|
|Stakeholder Input Deadline ‡||May 21, 2020|
|Check-point meeting||July 29, 2020|
|pERC Meeting (target date)|
|Initial Recommendation Issued (target date)|
|Feedback Deadline (target date) ‡|
|pERC Reconsideration Meeting (target date)|
|Final Recommendation Issued (target date)|
|Notification to Implement Issued|
‡ 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.