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|Project Number||pCODR 10154|
|Strength||3.5 mg / mL|
|Funding Request||To be used in combination with GM-CSF, IL-2 and Retinoic acid (RA) for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line multi-agent, multimodal therapy|
|Review Status||Notification to Implement Issued|
|Pre Noc Submission||Yes|
|NOC Date||November 28, 2018|
|Manufacturer||United Therapeutics Corp.|
|Sponsor||United Therapeutics Corp.|
|Submission Date||October 1, 2018|
|Submission Deemed Complete||October 16, 2018|
|Submission Type||New Drug|
|Stakeholder Input Deadline ‡||October 16, 2018|
|Check-point meeting||November 29, 2018|
|pERC Meeting||February 21, 2019|
|Initial Recommendation Issued||March 7, 2019|
|Feedback Deadline ‡||March 21, 2019|
|Final Recommendation Issued||March 26, 2019|
|Notification to Implement Issued||April 10, 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.