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Posted On: 09/20/2021 9:07:31 PM
Post# of 148925
Quote:
EDSA's mab has good phase 2
Maybe
The run up was based on the press release of recovery for ECMO patients. Very small patient population and SOC was dexamethasone and IL-6 inhibitors which have shown little benefit in ECMO so easy to beat.
What makes me wonder is out of 198 patients at the interim why 33 were on ECMO. The trial accepted patients that were level 3 (no oxygen) to level 6 (mechanical intubation or ECMO). With more available patients at the lower levels that's where you'd expect the preponderance of patients (as in CD12). The trial also excluded those who were on mechanical ventilation or ECMO for 5 days or longer further narrowing the potential patient pool. It looks like the deck was being stacked towards critical patients.
Of interest is that they released the interim for ECMO and critically ill but not the rest of the patient population. Critically ill mortality at interim is p = .15. Expected critical mortality for full phase 3 might not be statistically significant. That numbers weren't shown for the full patient population means the results were almost certainly worse. At mimimum protocol would need to be changed for phase 3.
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