A couple of things I noted from this evening's Onty CC. Because of the clinical hold they actually dropped 156 patients that were included in the 1st IA and they were simply replaced with 156 newer patients that were enrolled after the hold. In essence, the 2nd look population wasn't really as old as we originally thought.
Kirkman also stated that the original protocol was 90% powered to show a 6 month OS benefit P .025 (control = 20 months) with a HR of .76/.77
I'm starting to wonder if the Waksal Brothers are advising Onty/Merck in this deal.
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