NorthWest Biotherapeutics Inc (NWBO)

[hyperopia]

Amgen’s timeline for Sotorasib using RTOR and Project Orbis: (which seems typical of BP's)

October 5, 2020 - Amgen announces positive topline phase 2 results for investigational KRAS G12C inhibitor sotorasib in advanced non-small cell lung cancer.
https://www.prnewswire.com/news-releases/amgen-announces-positive-topline-phase-2-results-for-investigational-kras-g12c-inhibitor-sotorasib-in-advanced-non-small-cell-lung-cancer-301145947.html

December 16, 2020 - Amgen Submits Sotorasib New Drug Application To U.S. FDA for its use in patients with KRAS G12C­–mutant locally advanced or metastatic NSCLC
https://www.amgen.com/newsroom/press-releases/2020/12/amgen-submits-sotorasib-new-drug-application-to-u-s--fda-for-advanced-or-metastatic-non-small-cell-lung-cancer-with-kras-g12c-mutation (Reviewed under RTOR Pilot Program)

December 24, 2020 - Amgen submit sotorasib marketing authorization application to the European Medicines Agency.
http://pharmabiz.com/NewsDetails.aspx?aid=134343&sid=2

May 28, 2021 - FDA Approves sotorasib the First Targeted Therapy for Lung Cancer Mutation Previously Considered Resistant to Drug Therapy
https://www.fda.gov/news-events/press-announcements/fda-approves-first-targeted-therapy-lung-cancer-mutation-previously-considered-resistant-drug

June 24, 2021 - Abstract published in NEJM
https://www.nejm.org/doi/full/10.1056/NEJMoa2103695

September 13, 2021 - UK’s MHRA approves Amgen’s sotorasib for non-small cell lung cancer (MHRA’s 2nd approval using Project Orbis)
https://www.pharmaceutical-business-review.com/news/uks-mhra-sotorasib-lung-cancer/

Still waiting for approval by EMA????