NorthWest Biotherapeutics Inc (NWBO)

[SkyLimit2022]

LC,

Let’s not start the timeline nonsense again. We are looking forward because we have reached the point in time when regulatory review has been initiated.

Looking back to critique the timeline has no significance. You could look back into the history of any drug technology and you would see a decade of development or multiple decades depending on which starting point you wish to consider for which component of any given drug.

If you wish to count foundational research as a starting point, then the development period would extend well beyond one or two decades for many drug technologies.

For example, the timeframe described below with regard to pembrolizumab is quite long and does not include the foundational research period that gave rise to PD-1 blockade technology:

“Keytruda (pembrolizumab) was in development for over a decade before its first FDA approval. The work on Keytruda began in 2003 at Organon, a Dutch pharmaceutical company. The research focused on developing antibody technology into a therapeutic agent for cancer immunotherapy. Merck & Co. later acquired the rights and further developed the drug.

Keytruda received its first FDA approval on September 4, 2014, for the treatment of advanced or unresectable melanoma. This approval came after key clinical trials demonstrated its effectiveness in increasing survival and reducing tumor size compared to existing treatments (citation:1,Development History of Keytruda (Pembrolizumab) – Creative Biolabs rAb Blog)(https://www.creativebiolabs.net/blog/development-history-of-keytruda-pembrolizumab/) (oai_citation:2,Meet the Dutch Scientists who Invented Keytruda, "The President's Drug")(https://www.labiotech.eu/interview/interview-keytruda-cancer-inventors/).

The journey from initial development to commercialization involved extensive research, multiple clinical trials, and regulatory reviews. Since its first approval, Keytruda has gained numerous additional approvals for various cancer types, solidifying its role as a foundational cancer treatment (citation:3,Keytruda Approvals: A Timeline | BioSpace)(https://www.biospace.com/article/keytruda-approvals-a-timeline) (citation:4,Keytruda (pembrolizumab) FDA Approval History - Drugs.com)(https://www.drugs.com/history/keytruda.html).

For more detailed information, you can explore the development history and approval timeline of Keytruda on resources like BioSpace and Creative Biolabs.”