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|Project Number||pCODR 10194|
|Indication||Advanced or Metastatic Breast Cancer|
|Funding Request||In combination with an aromatase inhibitor (AI) and a luteinizing hormone releasing hormone (LHRH) agonist for the treatment of pre/peri- menopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer, as initial endocrine-based therapy|
|Review Status||Under Review|
|Pre Noc Submission||Yes|
|NOC Date||February 7, 2020|
|Manufacturer||Novartis Pharmaceuticals Canada Inc.|
|Sponsor||Novartis Pharmaceuticals Canada Inc.|
|Submission Date||August 26, 2019|
|Submission Deemed Complete||September 10, 2019|
|Submission Type||New Indication|
|Stakeholder Input Deadline ‡||September 10, 2019|
|Check-point meeting||November 18, 2019|
|pERC Meeting||March 19, 2020|
|Initial Recommendation Issued||April 2, 2020|
|Feedback Deadline ‡||April 17, 2020|
|pERC Reconsideration Meeting||May 21, 2020|
|Final Recommendation Issued||June 4, 2020|
|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.