Replies to post #360481 on NorthWest Biotherapeutics Inc (NWBO)

[ATLnsider]

Evaluate, here are 2 recent / current pending NDAs that are being processed by the FDA under both the Real-Time Oncology Review (RTOR) program, and the Project Orbis program. The first new drug is Sotorasib, which is a new drug developed by Amgen, to treat non-small cell lung cancer (NSCLC):

https://www.prnewswire.com/news-releases/fda-grants-sotorasib-priority-review-designation-for-the-treatment-of-patients-with-kras-g12c-mutated-locally-advanced-or-metastatic-non-small-cell-lung-cancer-301229256.html

The second new drug is Belumosudil, which is a new drug developed by Kadmon Holdings, for the treatment of patients with chronic graft-versus-host disease (cGVHD):

https://finance.yahoo.com/amphtml/news/kadmon-announces-fda-acceptance-nda-130000820.html

Not only do I hope and believe that the new DCVax-L BLA will be reviewed & approved by the FDA and the other 3 or 4 regulatory authorities, to treat ndGBM & rGBM using the RTOR and the Project Orbis program, I also hope and believe that every new supplemental BLA approval of DCVax-L (alone or in combination with a PD-1 inhibitor) for other solid tumor cancers (colorectal, ovarian, lung, breast, prostate, etc.), will also be approved using the FDA’s RTOR and Project Orbis program.

I also hope and believe that NWBio will use this process for DCVax Drrect approvals too.These programs will significantly shorten the time it will take for NWBio to add multiple indications to the DCVax-L and DCVax Direct labels.