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Posted On: 03/07/2021 12:27:29 AM
Post# of 145875
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CD12 is an adaptive Phase 2b/3. You adapt the trial as you learn. I hope you all caught that in the extension to add another 140 critical patients (of which they have 45 and he said he could get another 100 easily) that they have also requested a new primary endpoint. They will now shift it from all cause mortality to days to hospital release. They showed a huge delta vs SOC in that stat. So if you now presceen for 65 or younger too, which showed lower deaths, it’s a slam dunk. Very important if FDA agrees with this change of endpoint. It informs the registration and IMD or EUA.
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