Last Updated : June 8, 2017
Details
Key Milestones2 | |
|---|---|
| Call for patient input posted | June 07, 2017 |
| Patient group input closed | July 27, 2017 |
| Clarification: - Patient input submission received | |
| Patient input summary sent for review to patient input groups | August 08, 2017 |
| Patient group comments on input summary closed | August 14, 2017 |
| Clarification: - Patient input summary feedback received | |
| Submission received | July 06, 2017 |
| Submission accepted for review | July 20, 2017 |
| Review initiated | July 21, 2017 |
| Draft CDR review report(s) sent to applicant | October 25, 2017 |
| Comments from applicant on draft CDR review report(s) received | November 03, 2017 |
| Redaction requests from applicant on draft CDR review report(s) received | November 10, 2017 |
| CDR review team's comments on draft CDR review report(s) sent to applicant | December 01, 2017 |
| Canadian Drug Expert Committee (CDEC) meeting | December 13, 2017 |
| CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plans | January 02, 2018 |
| Embargo period ended and validation of redacted CDR review report(s) received | January 16, 2018 |
| CDEC Final Recommendation issued to applicant and drug plans | January 23, 2018 |
| CDEC Final Recommendation posted | January 25, 2018 |
| Final CDR review report(s) and patient input posted | February 06, 2018 |
Last Updated : April 18, 2018
Details
‡ 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.
Last Updated : March 19, 2018
Details
Key Milestones2 |
|
|---|---|
| Call for patient input posted | June 05, 2017 |
| Patient group input closed | July 25, 2017 |
| Clarification:
- Patient input submission received |
|
| Patient input summary sent for review to patient input groups | September 12, 2017 |
| Patient group comments on input summary closed | September 18, 2017 |
| Clarification:
- Patient input summary feedback received |
|
| Submission received | August 08, 2017 |
| Submission accepted for review | August 22, 2017 |
| Review initiated | August 23, 2017 |
| Draft Canada's Drug Agency review report(s) sent to applicant | November 07, 2017 |
| Comments from applicant on draft Canada's Drug Agency review report(s) received | November 16, 2017 |
| Redaction requests from applicant on draft Canada's Drug Agency review report(s) received | November 23, 2017 |
| Canada's Drug Agency review team's comments on draft Canada's Drug Agency review report(s) sent to applicant | December 01, 2017 |
| Canadian Drug Expert Committee (CDEC) meeting | December 13, 2017 |
| CDEC recommendation & redacted Canada's Drug Agency review report(s) sent to applicant and drug plans | January 03, 2018 |
| Embargo period ended and validation of redacted Canada's Drug Agency review report(s) received | January 17, 2018 |
| CDEC Final Recommendation issued to applicant and drug plans | January 24, 2018 |
| CDEC Final Recommendation posted | January 26, 2018 |
| Final Canada's Drug Agency review report(s) and patient input posted | February 08, 2018 |
Last Updated : May 8, 2019
Details
Request for Resubmission: Eligible (Decision Date: May 24, 2018)
Key Milestones2 |
|
|---|---|
| Call for patient input posted | June 01, 2017 |
| Patient group input closed | July 21, 2017 |
| Clarification:
- Patient input submission received |
|
| Patient input summary sent for review to patient input groups | July 27, 2017 |
| Patient group comments on input summary closed | August 04, 2017 |
| Clarification:
- Patient input summary feedback received |
|
| Submission received | June 28, 2017 |
| Submission accepted | July 13, 2017 |
| Review initiated | July 14, 2017 |
| Draft Canada's Drug Agency review report(s) sent to sponsor | October 02, 2017 |
| Comments from sponsor on draft Canada's Drug Agency review report(s) received | October 12, 2017 |
| Redaction requests from sponsor on draft Canada's Drug Agency review report(s) received | October 19, 2017 |
| Canada's Drug Agency review team's comments on draft Canada's Drug Agency review report(s) sent to sponsor | November 03, 2017 |
| Canadian Drug Expert Committee (CDEC) meeting | November 15, 2017 |
| CDEC recommendation & redacted Canada's Drug Agency review report(s) sent to sponsor and drug plans | November 29, 2017 |
| Embargo period ended and validation of redacted Canada's Drug Agency review report(s) received | December 13, 2017 |
| CDEC Final Recommendation issued to sponsor and drug plans | December 20, 2017 |
| CDEC Final Recommendation posted | December 22, 2017 |
| Final Canada's Drug Agency review report(s) and patient input posted | January 10, 2018 |
Last Updated : June 12, 2020
Details
Key Milestones2 | |
|---|---|
| Call for patient input posted | May 31, 2017 |
| Patient group input closed | July 20, 2017 |
| Clarification: - Patient input submission received | |
| Patient input summary sent for review to patient input groups | July 25, 2017 |
| Patient group comments on input summary closed | August 01, 2017 |
| Clarification: - Patient input summary feedback received | |
| Submission received | June 28, 2017 |
| Submission accepted | July 13, 2017 |
| Review initiated | July 14, 2017 |
| Draft Canada's Drug Agency review report(s) sent to sponsor | September 28, 2017 |
| Comments from sponsor on draft Canada's Drug Agency review report(s) received | October 10, 2017 |
| Redaction requests from sponsor on draft Canada's Drug Agency review report(s) received | October 17, 2017 |
| Canada's Drug Agency review team's comments on draft Canada's Drug Agency review report(s) sent to sponsor | November 03, 2017 |
| Clarification: - Voluntarily withdrawn by the manufacturer on 2017-Nov-09 | |
Last Updated : June 18, 2020
Details
‡ 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.
Last Updated : January 22, 2018
Details
| Call for patient input posted | 17-Apr-17 |
|---|---|
| Patient group input closed | 06-Jun-17 |
| Clarification: - Patient input submission received | |
| Patient input summary sent for review to patient input groups | 26-Jun-17 |
| Patient group comments on input summary closed | 04-Jul-17 |
| Clarification: - Patient input summary feedback received | |
| Submission received | 15-May-17 |
| Submission accepted | 30-May-17 |
| Review initiated | 31-May-17 |
| Clarification: - Voluntarily withdrawn by the manufacturer on 2017-July-11 | |
Last Updated : July 21, 2025
Details
‡ 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.
Last Updated : January 11, 2018
Details
Key Milestones2 |
|
|---|---|
| Call for patient input posted | May 11, 2017 |
| Patient group input closed | June 30, 2017 |
| Clarification:
- Patient input submission received |
|
| Patient input summary sent for review to patient input groups | July 19, 2017 |
| Patient group comments on input summary closed | July 26, 2017 |
| Clarification:
- Patient input summary feedback received |
|
| Submission received | June 09, 2017 |
| Submission accepted for review | June 23, 2017 |
| Review initiated | June 26, 2017 |
| Draft CDR review report(s) sent to applicant | September 28, 2017 |
| Comments from applicant on draft CDR review report(s) received | October 10, 2017 |
| Redaction requests from applicant on draft CDR review report(s) received | October 17, 2017 |
| CDR review team's comments on draft CDR review report(s) sent to applicant | December 01, 2017 |
| Canadian Drug Expert Committee (CDEC) meeting | December 13, 2017 |
| CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plans | January 02, 2018 |
| Embargo period ended and validation of redacted CDR review report(s) received | January 16, 2018 |
| CDEC Final Recommendation issued to applicant and drug plans | January 23, 2018 |
| CDEC Final Recommendation posted | January 25, 2018 |
| Final CDR review report(s) and patient input posted | February 08, 2018 |
Last Updated : April 12, 2018