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|Project Number||pCODR 10221|
|Strength||25 mg, 100 mg & 20 mg/mL|
|Indication||Neurotrophic Tyrosine Receptor Kinase|
|Funding Request||For the treatment of adult and pediatric patients with solid tumours that: have a Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and, have no satisfactory treatment options.|
|Review Status||Open for Input on Submission|
|Pre Noc Submission||No|
|NOC Date||July 10, 2019|
|Submission Date (Target Date)||November 13, 2020|
|Stakeholder Input Deadline (target date based on target submission date) ‡||December 4, 2020|
|Check-point meeting (target date)|
|pERC Meeting (target date)|
|Initial Recommendation Issued (target date)|
|Feedback Deadline (target date) ‡|
|pERC Reconsideration Meeting (target date)|
|Final Recommendation Issued (target date)|
|Notification to Implement Issued|
‡ 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.