SparkyReturns
$ICU For anyone new or those in back....
Seastar likely used data from the Neutralize-AKI trial which showed "probable benefit" and safety to get the 7th BDD for Sepsis. The FDA was also convinced that there is a critical unmet need and no other options. Now they just need to finish that study and can use the full data set to get not just 1 approval for AKI, but a 2nd standalone approval for Sepsis. With this device saving half of the people who would otherwise not go home, its not a question of whether they will be approved, but when.
Tomorrow could be a big inflection point as it will show further evidence of efficacy.
GL longs!
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