‡ 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.
Key Milestones2 | |
|---|---|
| Call for patient input posted | April 04, 2018 |
| Patient group input closed | May 24, 2018 |
| Clarification: - No patient input submission received | |
| Submission received | May 02, 2018 |
| Submission accepted | May 16, 2018 |
| Review initiated | May 17, 2018 |
| Draft Canada's Drug Agency review report(s) sent to sponsor | August 01, 2018 |
| Comments from sponsor on draft Canada's Drug Agency review report(s) received | August 13, 2018 |
| Redaction requests from sponsor on draft Canada's Drug Agency review report(s) received | August 15, 2018 |
| Clarification: - Voluntarily withdrawn by the manufacturer on 2018-08-14 | |
Key Milestones2 |
|
|---|---|
| Call for patient input posted | April 02, 2018 |
| Patient group input closed | May 22, 2018 |
| Clarification:
- Patient input submission received |
|
| Patient input summary sent for review to patient input groups | May 31, 2018 |
| Patient group comments on input summary closed | June 07, 2018 |
| Clarification:
- Patient input summary feedback received |
|
| Submission received | April 30, 2018 |
| Submission accepted for review | May 14, 2018 |
| Review initiated | May 15, 2018 |
| Draft CDR review report(s) sent to applicant | August 07, 2018 |
| Comments from applicant on draft CDR review report(s) received | August 16, 2018 |
| Redaction requests from applicant on draft CDR review report(s) received | August 23, 2018 |
| CDR review team's comments on draft CDR review report(s) sent to applicant | September 07, 2018 |
| Canadian Drug Expert Committee (CDEC) meeting | September 19, 2018 |
| CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plans | October 03, 2018 |
| Embargo period ended and validation of redacted CDR review report(s) received | October 29, 2018 |
| Clarification:
- Request for extension to embargo period received from the manufacturer - Embargo extension request granted - Reconsideration requested |
|
| Applicant's request for reconsideration placed on CDEC agenda | January 16, 2019 |
| CDEC Final Recommendation issued to applicant and drug plans | January 23, 2019 |
| CDEC Final Recommendation posted | January 25, 2019 |
| Final CDR review report(s) posted | February 07, 2019 |
Key Milestones2 |
|
|---|---|
| Call for patient input posted | April 02, 2018 |
| Patient group input closed | May 22, 2018 |
| Clarification:
- Patient input submission received |
|
| Patient input summary sent for review to patient input groups | - |
| Patient group comments on input summary closed | - |
| Submission received | April 30, 2018 |
| Submission accepted for review | May 14, 2018 |
| Review initiated | May 15, 2018 |
| Draft CDR review report(s) sent to applicant | August 07, 2018 |
| Comments from applicant on draft CDR review report(s) received | August 16, 2018 |
| Redaction requests from applicant on draft CDR review report(s) received | August 23, 2018 |
| CDR review team's comments on draft CDR review report(s) sent to applicant | September 07, 2018 |
| Canadian Drug Expert Committee (CDEC) meeting | September 19, 2018 |
| CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plans | October 03, 2018 |
| Embargo period ended and validation of redacted CDR review report(s) received | October 29, 2018 |
| Clarification:
- Request for extension to embargo period received from the manufacturer - Embargo extension request granted - Reconsideration requested |
|
| Applicant's request for reconsideration placed on CDEC agenda | January 16, 2019 |
| CDEC Final Recommendation issued to applicant and drug plans | January 23, 2019 |
| CDEC Final Recommendation posted | January 25, 2019 |
| Final CDR review report(s) posted | February 08, 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.
Key Milestones2 |
|
|---|---|
| Call for patient input posted | March 21, 2018 |
| Patient group input closed | May 10, 2018 |
| Patient input summary sent for review to patient input groups | June 21, 2018 |
| Patient group comments on input summary closed | June 29, 2018 |
| Clarification:
- Patient input summary feedback received |
|
| Submission received | May 18, 2018 |
| Submission accepted for review | June 04, 2018 |
| Review initiated | June 05, 2018 |
| Draft CDR review report(s) sent to applicant | August 20, 2018 |
| Comments from applicant on draft CDR review report(s) received | August 29, 2018 |
| Redaction requests from applicant on draft CDR review report(s) received | September 06, 2018 |
| CDR review team's comments on draft CDR review report(s) sent to applicant | October 04, 2018 |
| Canadian Drug Expert Committee (CDEC) meeting | October 17, 2018 |
| Clarification:
- Deferred to November 21, 2018 CDEC meeting |
|
| CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plans | December 03, 2018 |
| Embargo period ended and validation of redacted CDR review report(s) received | December 17, 2018 |
| CDEC Final Recommendation issued to applicant and drug plans | December 24, 2018 |
| CDEC Final Recommendation posted | January 3, 2019 |
| Final CDR review report(s) and patient input posted | January 30, 2019 |
Key Milestones2 |
|
|---|---|
| Call for patient input posted | March 19, 2018 |
| Patient group input closed | May 08, 2018 |
| Clarification:
- Patient input submission received |
|
| Patient input summary sent for review to patient input groups | May 14, 2018 |
| Patient group comments on input summary closed | May 22, 2018 |
| Clarification:
- Patient input summary feedback received |
|
| Submission received | April 17, 2018 |
| Submission accepted for review | May 01, 2018 |
| Review initiated | May 02, 2018 |
| Draft CDR review report(s) sent to applicant | July 20, 2018 |
| Comments from applicant on draft CDR review report(s) received | July 31, 2018 |
| Redaction requests from applicant on draft CDR review report(s) received | August 08, 2018 |
| CDR review team's comments on draft CDR review report(s) sent to applicant | September 07, 2018 |
| Canadian Drug Expert Committee (CDEC) meeting | September 19, 2018 |
| CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plans | October 01, 2018 |
| Embargo period ended and validation of redacted CDR review report(s) received | October 16, 2018 |
| CDEC Final Recommendation issued to applicant and drug plans | October 23, 2018 |
| CDEC Final Recommendation posted | October 25, 2018 |
| Final CDR review report(s) and patient input posted | October 29, 2018 |
‡ 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.
‡ 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.
‡ 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.