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|Project Number||pCODR 10140|
|Strength||4mg and 10mg|
|Indication||Renal Cell Carcinoma (RCC)|
|Funding Request||In combination with everolimus for the treatment of patients with advanced or metastatic, clear-cell RCC following one prior VEGF-targeted therapy.|
|Review Status||Notification to Implement Issued|
|Pre Noc Submission||No|
|NOC Date||September 13, 2017|
|Submission Date||June 8, 2018|
|Submission Deemed Complete||June 15, 2018|
|Submission Type||New Indication|
|Prioritization Requested||Requested and Not Granted|
|Stakeholder Input Deadline ‡||June 22, 2018|
|Check-point meeting||August 14, 2018|
|pERC Meeting||October 18, 2018|
|Initial Recommendation Issued||November 1, 2018|
|Feedback Deadline ‡||November 15, 2018|
|pERC Reconsideration Meeting||December 13, 2018|
|Final Recommendation Issued||January 4, 2019|
|Notification to Implement Issued||January 21, 2019|
‡ 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.