The FDA does not require patient-level data from an external control arm unless the sponsor decides to use that control for comparison. According to the FDA’s 2023 guidance, sponsors must submit patient-level data only for the real-world data sources they analyze as part of their clinical evidence. If NWBO relies only on structured data from its compassionate use program, then no external control arm is necessary, and therefore no patient-level data from one is needed. This requirement only applies if a sponsor includes an external control in their study design; it is not a blanket mandate.
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