NorthWest Biotherapeutics Inc (NWBO)

[Lykiri]

DCVax-L in the USA

FDA Submission process: Orphan Designation / Unknown (Real Time Oncology Review, imo)
BLA Submission date: ?
BLA Acceptance date: ?
BLA Approval date: ?

hoffmann6383,
Real Time Oncology Review (RTOR)
I doubt it.

A July 2022 draft guidance on RTOR states the program “may not be suitable for certain biological products, such as cell and gene therapies, for which complex manufacturing and product characteristics need to be considered in evaluating the safety and efficacy of the product.” (Also see “US FDA’s Real-Time Oncology Review Program Is No Guarantee For Early Approval” – Pink Sheet, 27 Jul, 2022.)
When asked about the prospects for extending the RTOR philosophy to CBER, OTAT’s Bryan noted the complicated nature of gene and cell therapies could pose challenges.
With OCE’s RTOR program, “there’s a bit of cherry picking” in that the most complicated products are excluded, he said.
“You don’t put the ones that have CMC manufacturing issues into Real-Time Oncology Review. Now maybe that will evolve. So we have to find things in cell and gene therapy that aren’t complicated, that don’t have great manufacturing issues. And I think we’ll be doing that with some efficacy supplements, but probably not original BLAs for some time.”

https://friendsofcancerresearch.org/news/pink-sheet-us-fda-eyes-project-orbis-type-approach-for-cell-and-gene-therapies/