Replies to post #423455 on 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

[Doc logic]

hoffmann6383,

What we have here is a failure to (ex)communicate ; ). Best wishes.

[Nick119]

Yes - thanks Hoffman. @ATLnsider is who got me on this train of thought earlier this year with some great research he's done.

NWBO does have fast-track designation with other RA's, but for some reason their conversations with the FDA throughout the history of NWBO's operation have been kept close to the vest.

Here's their fast track designation in the UK: https://www.bioprocessonline.com/doc/nw-bio-s-cancer-vaccine-first-to-receive-pim-designation-in-u-k-s-early-access-scheme-0001

[biosectinvestor]

Hi Hoffmann6383

Project Orbis is not itself a accelerated program, but a party needs to be designated with an accelerated status to be in Project Orbis.

If they have the status in the US, they can get into Orbis, not sure that the status in the UK gives them access to Orbis. But certification of their facility for GMP would be a designation, along with a plan that was realistic for scaling manufacturing, to get them into an accelerated program with the FDA. There are other requirements but those are easily ticked off.

The focus on manufacturing, which I posted in detail on last summer, with quotes and links to the relevant documents, is for the acceleration of approval and then hopefully into Project Orbis because of that designation.