Replies to post #753018 on NorthWest Biotherapeutics Inc (NWBO)

[j e d]

how does this change average (and range) of approval times? thanks

[DJknows]

Quick research shows it was first approved in November 2015 then further March of 2017:

https://www.fda.gov/drugs/resources-information-approved-drugs/osimertinib-tagrisso

Osimertinib was approved for medical use in the United States in November 2015, and in the European Union in February 2016.

https://pmc.ncbi.nlm.nih.gov/articles/PMC6072417/#:~:text=The%20initiation%20of%20the%20project,wild%2Dtype%20forms%20of%20EGFR.

The initiation of the project that led to the discovery of osimertinib at AstraZeneca was triggered in May 2009 at the Alderley Park research site, after forty compounds were tested in biochemical assays against the EGFR T790M mutant and wild-type forms of EGFR.

I believe this drug was first submitted in June of 2015 so roughly took 5-6 months to garner FDA approval:

https://www.fda.gov/media/97119/download