AI
Sunday, December 20, 2020 3:39:34 PM
I also believe that, not only was the FDA the 1st regulatory authority (RA) to buy-in the new SAP & revised endpoints, I think NWBio is in week 6 to 9 of the 22-week Real-Time Oncology Review (RTOR) program process. The FDA Oncology Center of Excellence RTOR program aims to explore a more efficient review process to ensure that safe and effective treatments are available to patients as early as possible.
The FDA RTOR program enables new oncology drugs & biologics to be reviewed & approved significantly quicker. The RTOR program was used by Merck to get FDA approval for Keytruda faster as a first line treatment for colorectal cancer, in July 2020. Here is a link for the Merck Keytruda FDA approval using the RTOR program:
https://immuno-oncologynews.com/2020/07/01/fda-approves-keytruda-first-line-therapy-certain-advanced-colorectal-cancers/
I am sure that Dr. Kevin Duffy was aware of the FDA’s RTOR program & he probably shared information with NWBio about how to take advantage of the RTOR program. Here is a link & images about the RTOR program:
https://www.fda.gov/about-fda/oncology-center-excellence/real-time-oncology-review-pilot-program
The FDA RTOR program enables new oncology drugs & biologics to be reviewed & approved significantly quicker. The RTOR program was used by Merck to get FDA approval for Keytruda faster as a first line treatment for colorectal cancer, in July 2020. Here is a link for the Merck Keytruda FDA approval using the RTOR program:
https://immuno-oncologynews.com/2020/07/01/fda-approves-keytruda-first-line-therapy-certain-advanced-colorectal-cancers/
I am sure that Dr. Kevin Duffy was aware of the FDA’s RTOR program & he probably shared information with NWBio about how to take advantage of the RTOR program. Here is a link & images about the RTOR program:
https://www.fda.gov/about-fda/oncology-center-excellence/real-time-oncology-review-pilot-program
