Replies to post #688 on SeaStar Medical Holding Corp (ICU)

[Whalatane]

Well we already have the Pediatric data . That increases confidence that the adult data should be strong ...but maybe not as good as Pediatric ..
The EUPHRATES trial failed its primary end point. Thats unlikely with NEUTRALIZE-AKI due to the conservative design Dr Chung went with .
I dont know anything about Spectral Med ...but note ICU has several advantages ...prior pilot trials and the Pediatric trial
However I dont know if theres anything in the ICU adult trial design providing for an early stop or reducing enrollment ...or how much lea way the DSMB has on those decisions
JMO
Kiwi

[Whalatane]

Wondering if you have an opinions on the following
1) Chance of SCD being deemed a Class 3 device classification by the FDA following approval for Adult patients ...that would probably extend the life of their key patent another 5 yrs .
Being approved for the pediatric indication should help towards a Class 3 classification

2) Fresenius buying them if / when they get approval for the adult indication ...which IMHO would increase if they got a Class 3 device classification .
Fresenius currently makes their SCD cartridges I think .

Kiwi