NorthWest Biotherapeutics Inc (NWBO)

[SkyLimit2022]

Yes …



Posting the JCI link was a gift—I’ll have to agree on that one! Highlighting JCI really was a mic-drop moment for LC! 😉

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


https://www.prnewswire.com/news-releases/northwest-biotherapeutics-announces-that-a-marketing-authorization-application-has-been-submitted-to-the-uk-mhra-for-dcvax-l-for-glioblastoma-302021038.html



Combo is King!

https://clinicaltrials.gov/ct2/show/NCT04201873



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 first announcement of a regulatory filing for marketing was announced this month!

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 was a prerequisite of the MAA application that was submitted recently in December 2023.

“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