jmf123
Oct 3, 2:46 PM
$ICU Part 2:
This has significant implications for SeaStar’s current NEUTRALIZE-AKI, its pivotal adult AKI trial, (adult indication represents more than 200,000 U.S. patients annually). If the final 50-patient SAVE population demonstrates something like the previously observed mortality improvement with convincing statistical support and no emerging safety signal, you would have:
Original pediatric studies → FDA authorization → commercial real-world patients → completed FDA-mandated registry → similar survival signal.
That's a much stronger clinical narrative than SeaStar had when QUELIMMUNE was originally authorized. If the 50-patient SAVE cohort again lands around 70–80% survival, while a well-matched historical cohort is around 50%, we would have repeated evidence that SCD-treated patients are experiencing materially better outcomes. That's meaningful mechanistic/clinical corroboration going into the adult readout.
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