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pharmeng

04/27/15 6:32 PM

#6976 RE: BuyMyAsk #6958

so many posts today. trying to catch up...

I'd just be unsure if FDA would deem IL-6 reduction meaningful enough. I think a lot of people agree that high IL-6 correlates with increased mortality, but it is more unknown if reduction of that would actually decrease mortality. There are a lot of other things going on besides just cytokines in sepsis as the cause of sepsis could be from many things. Hence, I'm not sure it'd be an acceptable surrogate endpoint.

Also, let's say it got approved through EAP based on cytokines alone. Without more data, I'd think adoption rate would be similar to what we are seeing now.