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|Project Number||pCODR 10176|
|Strength||50 mg/vial & 25 mg/mL|
|Funding Request||For the treatment of patients with metastatic squamous NSCLC in combination with carboplatin and either paclitaxel or nab-paclitaxel, in adults with no prior systemic chemotherapy treatment for metastatic NSCLC|
|Review Status||Notification to Implement Issued|
|Pre Noc Submission||Yes|
|NOC Date||July 4, 2019|
|Submission Date||February 8, 2019|
|Submission Deemed Complete||February 25, 2019|
|Submission Type||New Indication|
|Stakeholder Input Deadline ‡||February 25, 2019|
|Check-point meeting||May 21, 2019|
|pERC Meeting||October 17, 2019|
|Clarification||The pCODR Expert Review Committee (pERC) Recommendation was deferred on September 19, 2019 pending additional information from the review team.|
|Initial Recommendation Issued||October 31, 2019|
|Feedback Deadline ‡||November 14, 2019|
|pERC Reconsideration Meeting||December 12, 2019|
|Final Recommendation Issued||January 3, 2020|
|Notification to Implement Issued||January 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.