Friday, March 05, 2021 8:27:39 PM
I believe that the FDA is the lead regulatory agency (RA), and it will review the DCVax-L TLD first. I am already on record stating that I believe NWBio may already be using the new FDA Real-Time Oncology Review (RTOR) program, that allows new and supplemental drug & biologic applications to be submitted, reviewed, and approved faster. NWBio only has to submit the DCVax-L TLD to the FDA to get the DCVax-L BLA process started via RTOR.
https://www.fda.gov/about-fda/oncology-center-excellence/real-time-oncology-review-pilot-program
In fact, the average time from submission of a new BLA or NDA to FDA approval was 3.3 months under the FDA RTOR program:
https://clincancerres.aacrjournals.org/content/27/1/11
DCVax-L is perfectly suited to take advantage of the FDA RTOR program.
https://www.amgen.com/stories/2020/12/decoding-5-recent-regulatory-and-development-steps-for-sotorasib
The FDA oncology group is clearly reinforcing the very deliberate message that cancer patients would not be forgotten even as the pandemic became public health priority number one.
https://pink.pharmaintelligence.informa.com/PS143715/US-FDAs-Three-Review-Speeds-Standard-Priority--And-Oncology
Not only do I believe NWBio may be using the FDA RTOR program for DCVax-L, I also believe NWBio may be using the FDA new Project Orbis program in conjunction with the RTOR program.
The FDA Oncology Center of Excellence (OCE) established Project Orbis to allow for the concurrent submission, review and approval of new oncology drugs and biologics in 6 different countries, by 6 different regulatory authorities at the same time.
These countries include: US, UK and Canada. I believe that DCVax-L could be approved in at least 3 different countries at the same time, and within 3 to 6 months from submission of the completed & accepted new BLA.
https://www.fda.gov/news-events/fda-voices/project-orbis-strengthening-international-collaboration-oncology-product-reviews-faster-patient
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