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Re: Steady_T post# 414932

Thursday, 05/11/2023 5:11:27 PM

Thursday, May 11, 2023 5:11:27 PM

Post# of 464896
I will just repost below references and ask once again, why so much focus on wanting a P4 trial vs. a P3? This in a context where AA is much more likely be achieved from the P2b trial when a P3 trial is already planned and initiated?

Separating clinical research from commercial access to a drug is much to be preferred for all the reasons here:

https://jamanetwork.com/journals/jama/fullarticle/2801050

https://www.fiercebiotech.com/biotech/fdas-pazdur-have-your-cancer-confirmatory-trial-underway-accelerated-approval-expect

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5487744/
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