Replies to post #546772 on NorthWest Biotherapeutics Inc (NWBO)

[SkyLimit2022]

Thanks for asking.

Murcidencel has been studied in three trials and only one had an ECA. But if you want to know about ECA approvals:

45 have been approved on an ECA —that is significant going back 20 yrs in history—only about 40 drugs are approved each year roughly if I recall correctly.

In terms of cancer drugs specifically that were approved on ECAs: Erdafitinib, Selumetinib, Blinatumomab, Keytruda+lenvatinib combo, and several combos for renal cancer … and others that I am sure I have forgotten.

I recommend researching ECA approvals further for yourself. Include RAs abroad and the evolving stance of the FDA toward RWE in your search.



https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track

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