Replies to post #546781 on NorthWest Biotherapeutics Inc (NWBO)

[SkyLimit2022]

Thanks for the reply.

Verify each of the drugs that I have named below—FDA approvals and the trial design for each study are public information available to anyone who wants to check.

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/drugs/news-events-human-drugs/fda-approval-demonstrates-role-real-world-evidence-regulatory-decision-making-drug-effectiveness



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

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

[SkyLimit2022]

These are some great source. Read as much as you can to get an accurate sense of the FDA’s stance overall as public service institution. They are careful, but also want drugs to be accessible to those who need them.

https://www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/considerations-use-real-world-data-and-real-world-evidence-support-regulatory-decision-making-drug

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=314.126#:~:text=314.126%20Adequate%20and%20well%2Dcontrolled,placebo%20effect%2C%20or%20biased%20observation.

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

https://www.fda.gov/drugs/news-events-human-drugs/fda-approval-demonstrates-role-real-world-evidence-regulatory-decision-making-drug-effectiveness

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

[X Master]

Yea, Your Wrong again and again and again.