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|Project Number||pCODR 10034|
|Brand Name||Stivarga (GIST)|
|Strength||40 mg Tablets|
|Indication||Gastrointestinal Stromal Tumours|
|Funding Request||Treatment of patients with metastatic and/or unresectable gastrointestinal stromal tumours (GIST) who have had disease progression on or intolerance to imatinib mesylate, and sunitinib malate treatment|
|Review Status||Notification to Implement Issued|
|Pre Noc Submission||No|
|NOC Date||October 4, 2013|
|Submission Date||October 11, 2013|
|Submission Deemed Complete||October 29, 2013|
|Submission Type||New Indication|
|Prioritization Requested||Not Requested|
|Stakeholder Input Deadline ‡||October 28, 2013|
|Check-point meeting (target date)||December 3, 2013|
|pERC Meeting||February 20, 2014|
|Initial Recommendation Issued||March 6, 2014|
|Feedback Deadline ‡||March 20, 2014|
|pERC Reconsideration Meeting||April 17, 2014|
|Final Recommendation Issued||May 2, 2014|
|Notification to Implement Issued||May 20, 2014|
‡ 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.