FDA and "rest of world" very different animals fellas. The rest of world or CE mark is safety based. The FDA will want their device cake and the ability to consume it's efficacy as well. I know we apparently treated the more difficult group during our German Sepsis Trial, however our results on the efficacy side were alarmingly low. I have read that because we treated many that were on dialysis, we achieved a negative 17% efficacy over the standard of care. Please correct me if I'm wrong.
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