RE:RE:RE:Key remaining QuestionsI think that they may have better info because they are 'insiders'. Do you get preferential treatment when you put in that much money? I wouldn't know because I have never had 1% of the amount they 'invested'.
I do like what was said in the MD & A but you never know what the FDA will see as pertinent. I do NOT like that one of the members of the review board is/was associated with CTSO, a competitor (in words only!).:
In patients with septic shock, MODS>9 and a baseline EAA ≥ 0.6 and < 0.9 (n=194) the PMX treatment group demonstrated an absolute reduction in mortality of 14% at 14 days (p =0.0103), 10.7% at 28 days (p=0.0474) and 11% at 90 days (p = 0.0383), when baseline APACHE and mean arterial pressure were controlled in each arm. At 28 days, the relative reduction in mortality was 30%. Survival over time analysis
showed a statistically significant and sustained increase in survival at all three time points: 52% risk reduction at 14 days (Hazard Ratio [“HR”] 0.48, p= 0.0189), 42% risk reduction at 28 days (HR 0.585, p =
0.0429) and 41% risk reduction at 90 days (HR 0.594, p=0.0373).
In this patient population, an improvement in organ function was seen in the PMX treated group compared to the sham group. There was a statistically significant increase in mean arterial blood pressure 72 hours
post treatment for the PMX group (p=0.0462) and a substantial increase in days alive and free from mechanical ventilator support [median difference of 14 days, (p=0.0043)].
Furthermore, the trial data indicates that for patients where no bacteria could be identified by culture yet were highly endotoxemic (approximately one third of the n=194 group), treatment with the PMX cartridge had a 28 day mortality of 21% versus 42% for the sham group (p=0.046), a relative risk reduction of 50%. These patients appear to be at higher risk for baseline mortality, with endotoxemia likely due to translocation of endotoxin from the gastro-intestinal system. With no microbiology targets to treat there are fewer options left to help these patients.