Wednesday, November 22, 2023 7:30:43 PM
Thank you for highlighting the MHRA!
The forthcoming NICE appraisal of the DCVax-L cell-based technology will be significant as well. 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
Believe carefully. This is the greatest and most powerful lesson that I have learned since arriving on Earth. Examine what you believe about yourself most importantly, and then believe carefully as you interact with the world.
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