When was the last P3 patient treated???
ANSWER: Late Sept. 2016. Wasn't that 29 months ago???
SOO,anyone think there are issues going back that far??? AND the FDA has made zero comments in that time???
To the best of my recollection; P3 patients that expired within their first 6 months were excluded from the trial.
AFTER 6 months cause of death is not a factor..... it's mortality between the TWO groups that the FDA will evaluate.
The FDA assumed that would/could happen and actually required LESS than 880 patients.
My recollection was 11% (880-96=784 ).
The FDA is in charge of the P3, NOT a CEO, NOR message board posters.
I was beginning to wonder if the P3 ends after 298 spread sheets.
Per the FDA the P3 is OVER ,COMPLETED.
BTW : The P3 patient tally is posted ( EXCLUDING the first CRO patients.)