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PlanTrader

03/23/21 1:43 PM

#36375 RE: drkazmd65 #36374

drkaz, Thanks, I appreciate the perspective. The "less clearly, but without being a literal failure" type of situation is what I was wondering about. You answered that, in that it's possible for that to be the case. Let's hope for clarity!
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BRMachine

03/24/21 6:48 AM

#36398 RE: drkazmd65 #36374

Agreed. Mostly a binary event, but a little bit of a gray area just below the primary endpoint of 10% improvement in overall survival. The FDA has lowered the bar in the years since the Multikine trial was designed and anything above 8% may still receive approval, however there would be downward pressure on the pps, at least in the short term.