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Re: theswordman post# 688

Friday, 08/01/2025 7:38:39 PM

Friday, August 01, 2025 7:38:39 PM

Post# of 1162
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
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