NorthWest Biotherapeutics Inc (NWBO)

[SkyLimit2022]

HyGro,

The DCVax-L cell-based platform technology is a fascinating medical innovation to research and read about. In combination with other technologies, it is even more intriguing!

Combo is King!

https://www.jci.org/articles/view/169314

This study found that autologous tumor lystate-loaded dendritic cell vaccination plus standard of care (SOC) was associated with improved survival in both newly diagnosed & recurrent glioblastoma compared with matched controls who received SOC treatment. https://t.co/Uso7Pkh1Kt

— JAMA Oncology (@JAMAOnc) February 15, 2023

https://doi.org/10.3171/2020.12.FOCUS20954

https://finance.yahoo.com/news/northwest-biotherapeutics-announces-dr-linda-140000962.html

The U.S. NIH has supported the DCVax-L platform for years, and the NIH renewed its support in 2022 to continue to fund the development of this technology and to fund research into combination therapies.

NIH-funded DCVax-L research is ongoing at UCLA today.

NIH grants are peer-reviewed and the research that NIH funds is highly scrutinized in advance of the award and also intermittently for the term of the various research projects.


https://www.uclahealth.org/news/fda-approval-brain-cancer-alzheimers




https://www.uclahealth.org/news/brain-cancer-discovery-clinical-trials

https://www.uclahealth.org/news/ucla-received-590-million-in-nih-funding-second-highest-total-for-academic-medical-centers-in-2020



https://www.fda.gov/science-research/advancing-regulatory-science/fda-nih-joint-leadership-council-charter




FDA is of course the focus, but I think that the U.K. will prove vastly significant too! King’s College and the Specials Program and MHRA developments are all very significant!

Additionally, I recommend that you review the forthcoming NICE appraisal of the DCVax-L cell-based technology. Stay tuned!

https://www.nice.org.uk/guidance/indevelopment/gid-ta10143

Britain's Medicines and Healthcare products Regulatory Agency (MHRA) will officially join #ProjectOrbis on January 1 and work with regulators in the US, Canada, Australia, Singapore and Switzerland on assessing new treatments. https://t.co/JjaXoq6yfh

— FDA Oncology (@FDAOncology) October 5, 2020

https://www.fda.gov/about-fda/oncology-center-excellence/project-orbis





https://www.kcl.ac.uk/people/keyoumars-ashkan

#CancerResearch #Cancers #cancermoonshot #GBM #Immunotherapy #oncology $nwbo #murcidencel #DCVax #CellTherapy https://t.co/BnJHM3myP9

— Blake (@MC17595091) August 13, 2023

The MIA was approved recently and is evidence of a regulatory filing plan that has begun to unfold. Further RA applications have been under construction for a significant period of time and include a voluminous catalog of clinical data and analyses. The announcements of regulatory filings are forthcoming.

The recent MIA approval is an important step in the regulatory process, and this commercial manufacturing license will allow DCVax-L to be exported globally from Sawston. The MIA is a prerequisite of the MAA application.

“Companies applying for a marketing authorisation (also known as a product licence) need to have a manufacturer licence first. The manufacturer licence will be granted first providing the product is in the process of being approved.” —MHRA

https://www.gov.uk/guidance/apply-for-manufacturer-or-wholesaler-of-medicines-licences

https://finance.yahoo.com/news/northwest-biotherapeutics-advent-bioservices-announce-234600744.html

https://finance.yahoo.com/news/northwest-biotherapeutics-announces-approval-pediatric-133900403.html

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=172639755%5B/color%5D

Explore Professor Keyoumars Ashkan's passion for neurosurgery and his love for @KingsCollegeNHS below as part of their #BrilliantPeople series🧠👇@KingsNeuro @KingsIoPPN https://t.co/yGKt2681Ie

— King's College London (@KingsCollegeLon) May 25, 2022

https://brownneurosurgery.com/breakthrough-brain-cancer-vaccine/

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