NorthWest Biotherapeutics Inc (NWBO)

[SkyLimit2022]

ex,

For a reliable appraisal of the trial, its design, and the significance of the resulting survival data, it is advisable to refer to the analyses of qualified physicians. Such an analysis can be found on the JAMA Oncology website where the independent peer review was published.

The forthcoming regulatory advisory from MHRA will further enlighten the significance the clinical data, and an assessment from MHRA may be available in advance of advisory decisions from FDA and regulators in other nations.

Additionally, I recommend that you review the forthcoming NICE appraisal of the DCVax-L cell-based technology when it is published.

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

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