70% of deaths of patients with LVAD implantation is related to multiple organ failure and sepsis. One ☝ of the predictors of sepsis is GI bleeding and in the Ph2 LVAD trial, this reduction was highly significant. Can this become a surrogate endpoint for early clinical benefit for an AA even though it was a Ph2 trial? Quite possibly - it is incumbent on the company in putting together a good case in its pre-BLA meeting.
This opportunity was not expected but would likely attract the best partnering candidate.
2024 Here we go again., page-367
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