RE:Why these two things are importantJosh,
Despite the fact that you clearly dislike the company now, and have some kind of personal vendeta against it, you have raised interesting points that I have tried to consider. I have to say though, that this point I do not feel holds weight.
The entire point of the end of the trial was to test an assumption of "the more endotoxin in the system, the greater effect of the device." As we all know, this was NOT the case, as the MODS >9 did not have a positive effect, which your personal statistics would point out.
However, You then conclude that this means the device is not safe across the board. This is factually not true. The device could be said to be harmful (not safe) for MODS>9, but the entire point of the study was to test efficacy and safety with the EAA in place to segregate the population. The EAA is mostly effective, that has not been in question. If that is the case then hospitals can effectively target the device to the group on which it will be most effective.
Therefore the request for approval to the FDA would not include the MODS>9 population and also stipulate its use on a specific population as determined safe by the EAA. So in relation to your 3 points:
"Remember the only reason why anybody still bothers with PMX after a failed trial is because 1. It’s a medical device, not a drug, thus a lower requirement; 2. PMX is supposed to be safe.; 3. There is no other available treatment. " These 3 aspects would still be positive and true, would they not?
thx,
DMcC