Senti,
Did that shareholder meeting preceed about March of 2015 or a little bit later or was it after the fact?
Double, blind - the physican and the patient know not what treatment you have received. There are times a drug cause an adverse effect that ‘unblinds’ some doctors and patients to treatment. This knowledge has an impact of the trial and while sometimes mistaken when actually placebo, it still gives them strength to know they have gotten the gold ticket, not the brown one.
Point being, this is why all around them must be blind to the treatment allocation. The impact of placebo affect and its inverse are well established. Even though NWBO may have had a reason to believe they knew the cause of the halt in new screening, they would not have verifiable knowledge. They would not have know how things proceeded and they would not have known who got what…even the 32 plus moved to treatment. Every patient remained blind.
Now just what was the data requested by FDA in 2015 and how much of a clue did it provide Linda? It didn’t seem like a long turn aroun as I recall.
My guess, case records for patients who have died. Maybe of the open label arm too. This could have also told them more than a reason, like progression status in patients who died. We could use the KM and all the data provided to recreate a guestimated number of deaths at that point in time. Suppose as an example…
110 death had occurred and the blinded monitors see roughly 55 in each blinded group. Hold it…time out…blow the whistle and through the flag. It works placebo must go. Not before taking a look, examine those cases. Ok, check, check, check, check…
Wait Aaron, yeah Joe, did you notice all of the placebo death have occurred early, but the treated patients we have that died have all already lived longer than expected, you guys know what that means, what Sharon, that everyone is living longer even those that die. Holy shit your right. Call FDA.
Instantly Germany…Halt, Halt, Halt…
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