Stat. Sig. 70% improval on SOC in Survival. That was the 'performance as expected'. Unfortunately that performance was partially recorded in the unblinded part of the trial and hence not fileable.
BTW, can anyone tell me what the optimal dosage of bavituximab is?
This really goes to the heart of how bad SK performed in rushing ahead with SUNRISE.
Some here might remember the discussion from 4-5 years ago as to why 1mg might well be more effective than 3mg. This was from before the P2 data came out. But what many might not catch is that the reason is the ratio of Bavi to b2pg1 is what is the key. If there is "more" Bavi than B2PG1, you end up with only one arm bound, and that does not work.
So, when stating that Sunrise failed in low b2pg1 patients, it is just as possible that Bavi was overdosed.
Whether dosing was "the" issue, or you are right and they should have switched to the BB based tech (nicked or not), the failure to understand this issue in early stage trials is simply pathetic.
Not only elephants, but a blind man not seeing the elephants.