RE:RE:DSMB MeetingRead Sept 14, 2015 News release. Here is a small portion for you to enjoy & it will answer your question about the quarterly DSMB meetings too... Statistical analysis was performed based on the actual composite mortality rate of patients randomized in the trial (approximately 50 percent) and the actual mortality rate of similar patients who were treated with the PMX medical device in Europe using the same protocol as the EUPHRATES trial (approximately 40 percent). The mortality data for these treated patients was drawn from a validated patient registry which has been tracking such information for over three years. The sample size recalculation is further supported by independent published data showing a predicted mortality rate in the range of 60 to 65 percent for patients in septic shock with a multiple organ dysfunction score (MODS) similar to those being randomized in our trial. The sample size has now been set at 446 evaluable patients (previously 650), of which 176 patients randomized after the protocol change will be considered for determination of the primary end point of 28-day mortality, as recommended by the FDA. The trial remains powered at 80 percent and the alpha remains at < 0.05 for its primary end point. the methodology for the sample size recalculation was presented to the dsmb at its quarterly meeting on september 3, 2015 and was accepted without further comment or the need for an interim analysis for this purpose, as had been previously contemplated. the company submitted its revised statistical analysis plan to the fda and it was accepted. 0.05="" for="" its="" primary="" end="" point.="" the="" methodology="" for="" the="" sample="" size="" recalculation="" was="" presented="" to="" the="" dsmb="" at="" its="" quarterly="" meeting="" on="" september="" 3,="" 2015="" and="" was="" accepted="" without="" further="" comment="" or="" the="" need="" for="" an="" interim="" analysis="" for="" this="" purpose,="" as="" had="" been="" previously="" contemplated.="" the="" company="" submitted="" its="" revised="" statistical="" analysis="" plan="" to="" the="" fda="" and="" it="" was="">