Key Milestones2 | |
|---|---|
| Call for patient input posted | November 22, 2017 |
| Patient group input closed | January 18, 2018 |
| Clarification: - No patient input submission received | |
| Submission received | December 21, 2017 |
| Submission accepted for review | January 12, 2018 |
| Review initiated | January 15, 2018 |
| Clarification: - Voluntarily withdrawn by the manufacturer on 2018-Mar-23 | |
‡ 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 | November 16, 2017 |
| Patient group input closed | January 12, 2018 |
| Clarification:
- No patient input submission received |
|
| Submission received | December 08, 2017 |
| Submission accepted for review | December 22, 2017 |
| Review initiated | January 02, 2018 |
| Draft CDR review report(s) sent to applicant | March 16, 2018 |
| Comments from applicant on draft CDR review report(s) received | March 27, 2018 |
| Redaction requests from applicant on draft CDR review report(s) received | April 04, 2018 |
| Clarification:
- No redactions requested by the applicant |
|
| CDR review team's comments on draft CDR review report(s) sent to applicant | May 04, 2018 |
| Canadian Drug Expert Committee (CDEC) meeting | May 16, 2018 |
| CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plans | May 30, 2018 |
| Embargo period ended and validation of redacted CDR review report(s) received | June 13, 2018 |
| CDEC Final Recommendation issued to applicant and drug plans | June 20, 2018 |
| CDEC Final Recommendation posted | June 22, 2018 |
| Final CDR review report(s) and patient input posted | June 22, 2018 |
Key Milestones2 | |
|---|---|
| Call for patient input posted | November 08, 2017 |
| Patient group input closed | January 04, 2018 |
Clarification: - Patient input submission received | |
| Patient input summary sent for review to patient input groups | January 11, 2018 |
| Patient group comments on input summary closed | January 18, 2018 |
Clarification: - Patient input summary feedback received | |
| Submission received | December 14, 2017 |
| Submission accepted for review | January 05, 2018 |
| Review initiated | January 08, 2018 |
| Draft CDR review report(s) sent to applicant | March 22, 2018 |
| Comments from applicant on draft CDR review report(s) received | April 03, 2018 |
| Redaction requests from applicant on draft CDR review report(s) received | April 10, 2018 |
| CDR review team's comments on draft CDR review report(s) sent to applicant | May 04, 2018 |
| Canadian Drug Expert Committee (CDEC) meeting | May 16, 2018 |
| CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plans | May 30, 2018 |
| Embargo period ended and validation of redacted CDR review report(s) received | June 13, 2018 |
| CDEC Final Recommendation issued to applicant and drug plans | June 20, 2018 |
| CDEC Final Recommendation posted | June 22, 2018 |
| Final CDR review report(s) and patient input posted | July 16, 2018 |
Key Milestones2 | |
|---|---|
| Call for patient input posted | November 03, 2017 |
| Patient group input closed | December 22, 2017 |
| Clarification: - Patient input submission received | |
| Patient input summary sent for review to patient input groups | January 10, 2018 |
| Patient group comments on input summary closed | January 17, 2018 |
| Clarification: - Patient input summary feedback received | |
| Submission received | December 07, 2017 |
| Submission accepted for review | December 21, 2017 |
| Review initiated | December 22, 2017 |
| Draft CDR review report(s) sent to applicant | March 15, 2018 |
| Comments from applicant on draft CDR review report(s) received | March 26, 2018 |
| Redaction requests from applicant on draft CDR review report(s) received | April 03, 2018 |
| CDR review team's comments on draft CDR review report(s) sent to applicant | May 04, 2018 |
| Canadian Drug Expert Committee (CDEC) meeting | May 16, 2018 |
| CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plans | May 30, 2018 |
| Embargo period ended and validation of redacted CDR review report(s) received | June 13, 2018 |
| CDEC Final Recommendation issued to applicant and drug plans | June 20, 2018 |
| CDEC Final Recommendation posted | June 22, 2018 |
| Final CDR review report(s) and patient input posted | July 09, 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.
Key Milestones2 |
|
|---|---|
| Call for patient input posted | October 04, 2017 |
| Patient group input closed | November 23, 2017 |
| Clarification:
- Patient input submission received |
|
| Patient input summary sent for review to patient input groups | December 04, 2017 |
| Patient group comments on input summary closed | December 11, 2017 |
| Clarification:
- Patient input summary feedback received |
|
| Submission received | November 02, 2017 |
| Submission accepted for review | November 16, 2017 |
| Review initiated | November 17, 2017 |
| Draft CDR review report(s) sent to applicant | February 16, 2018 |
| Comments from applicant on draft CDR review report(s) received | March 02, 2018 |
| Clarification:
- Extension request received from applicant - Extension granted |
|
| Redaction requests from applicant on draft CDR review report(s) received | March 09, 2018 |
| CDR review team's comments on draft CDR review report(s) sent to applicant | March 29, 2018 |
| Canadian Drug Expert Committee (CDEC) meeting | April 11, 2018 |
| CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plans | April 25, 2018 |
| Embargo period ended and validation of redacted CDR review report(s) received | June 07, 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 | September 19, 2018 |
| CDEC Final Recommendation issued to applicant and drug plans | September 26, 2018 |
| CDEC Final Recommendation posted | September 28, 2018 |
| Final CDR review report(s) and patient input posted | November 21, 2018 |
Key Milestones2 | |
|---|---|
| Call for patient input posted | September 27, 2017 |
| Patient group input closed | November 16, 2017 |
| Clarification: - Patient input submission received | |
| Patient input summary sent for review to patient input groups | November 22, 2017 |
| Patient group comments on input summary closed | November 29, 2017 |
| Clarification: - Patient input summary feedback received | |
| Submission received | October 26, 2017 |
| Submission accepted for review | November 09, 2017 |
| Review initiated | November 10, 2017 |
| Draft CDR review report(s) sent to applicant | February 05, 2018 |
| Comments from applicant on draft CDR review report(s) received | February 14, 2018 |
| Redaction requests from applicant on draft CDR review report(s) received | February 22, 2018 |
| CDR review team's comments on draft CDR review report(s) sent to applicant | March 09, 2018 |
| Canadian Drug Expert Committee (CDEC) meeting | March 21, 2018 |
| CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plans | April 05, 2018 |
| Embargo period ended and validation of redacted CDR review report(s) received | April 19, 2018 |
| CDEC Final Recommendation issued to applicant and drug plans | April 26, 2018 |
| CDEC Final Recommendation posted | April 30, 2018 |
| Final CDR review report(s) and patient input posted | May 08, 2018 |