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|Project Number||pCODR 10049|
|Strength||200 mg tablet|
|Indication||Metastatic Progressive Differentiated Thyroid Carcinoma (DTC)|
|Funding Request||Treatment of patients with locally advanced or metastatic, progressive differentiated thyroid carcinoma (DTC) refractory to radioactive iodine|
|Review Status||Notification to Implement Issued|
|Pre Noc Submission||No|
|NOC Date||June 27, 2014|
|Submission Date||December 19, 2014|
|Submission Deemed Complete||January 5, 2015|
|Submission Type||New Indication|
|Prioritization Requested||Requested and Granted|
|Stakeholder Input Deadline ‡||January 12, 2015|
|Check-point meeting (target date)||February 18, 2015|
|pERC Meeting||April 16, 2015|
|Initial Recommendation Issued||April 30, 2015|
|Feedback Deadline ‡||May 14, 2015|
|pERC Reconsideration Meeting||July 2, 2015|
|Clarification||Due to the number of items for deliberation, the pERC meeting was conducted over two days. Unable to reach quorum for either day around the target reconsideration meeting date of June 18, 2015, pERC held deliberations for all reconsideration items, including sorafenib, on July 2, 2015.|
|Final Recommendation Issued||July 16, 2015|
|Notification to Implement Issued||July 31, 2015|
‡ 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.