NorthWest Biotherapeutics Inc (NWBO)

[SkyLimit2022]

HyGro

Thank you for posting about the MHRA. The forthcoming regulatory developments will be quite significant. Commercialization and value measured in dollars requires RA approval.

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=171785690

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

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