Unless you're Novartis in which case the FDA will bend over backwards to approve on single arm trials and even if your trial fails to meet it's primary endpoints - see Jakafi and Entresto
https://endpts.com/novartis-entresto-facing-a-big-comeback-in-hard-to-treat-heart-failure-patients-scores-fda-nod-after-adcomm-cakewalk/
Ann: Half Year Report and Accounts (including Appendix 4D), page-107
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