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|Project Number||pCODR 10193|
|Funding Request||For the treatment of adult patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN), or mast cell leukemia (MCL).|
|Review Status||Notification to Implement Issued|
|Pre Noc Submission||No|
|NOC Date||October 3, 2018|
|Manufacturer||Novartis Pharmaceuticals Canada Inc.|
|Sponsor||Novartis Pharmaceuticals Canada Inc.|
|Submission Date||August 13, 2019|
|Submission Deemed Complete||August 27, 2019|
|Submission Type||New Indication|
|Stakeholder Input Deadline ‡||August 27, 2019|
|Check-point meeting||October 16, 2019|
|pERC Meeting||January 16, 2020|
|Initial Recommendation Issued||January 30, 2020|
|Feedback Deadline ‡||February 13, 2020|
|pERC Reconsideration Meeting||March 19, 2020|
|Final Recommendation Issued||April 2, 2020|
|Notification to Implement Issued||April 20, 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.