Replies to post #547051 on NorthWest Biotherapeutics Inc (NWBO)

[SkyLimit2022]

Thanks for the thoughtful reply.

This is truly just a distraction, but it is a great topic to research.

However, it is important to note and remember that murcidencel approval does not depend solely on ECA data.

Data collected from ECA comparison only comprise a fraction of the clinical efficacy data that exist for murcidencel today.

Murcidencel has been studied in three trials—only one of those three relied on an ECA. All clinical data are relevant to a regulatory application including those data gathered from other studies, interim analyses, and compassionate use. All three trials have produced substantial safety and efficacy data, and two of the three clinical trials ran for over a decade with survivors alive today.

https://jamanetwork.com/journals/jamaoncology/fullarticle/2798847

“Forty-five approvals were identified where FDA accepted external control data”

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8332598/