NorthWest Biotherapeutics Inc (NWBO)

[Lykiri]

hoffmann6383,

In December 2018, the program was expanded to include review of original drug applications and biological license applications for new molecular entities (NME).

The FDA Oncology Center of Excellence commenced the Real-Time Oncology Review (RTOR) pilot project in February 2018 to facilitate earlier submission of topline results and datasets to support an earlier start to the FDA application review. RTOR was initially begun to support supplemental drug applications to add new indications, dosing regimens, or other clinical information to the prescribing information, but was later expanded to include original new drug applications and biological license applications for new molecular entities (NME).
https://clincancerres.aacrjournals.org/content/27/1/11

Analysis of the Real-Time Oncology Review (RTOR) Pilot Program for Approvals of New Molecular Entities.(April 28, 2021)
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8081281/#CR2