Thank you for the excellent summary MM........ RE:Comments on Prof. Antonelli's presentation
More damn lies and statistics from Dr. CC Emma nee Josh PhD (Oxford and McGill). Re Safety. Antonelli was clear to point out - 22 year track record of excellent safety record on PMX. Serious Adverse events ~.01% in 150 articles published involving >7600 patients.----------------------On efficacy, n=295 did not need to be explained as that included patients that had dies, requested treatment be stopped, or did not get the full treatment. Why should those numbers be included in the Trial? ----------------------------Why Lower than the expected 20 %? Not Antonelli's job to speculate on this. But it was his job to present the fact that when patients are stratified (e.g. using assay readings/biomarkers/personalized medicine) results improved to 11 %, 15%, 21 % ....------------------- "Any modification of protocol (ie. increase column number for patients with EAA>0.9 within shorter span of time) will need to be confirmed by further studies (or trials)." - of course ! Future studies (after approval) would naturally be dosage studies (to determine the benefit of additional columns) . I would expect that to take many more years of study - likely resulting in greater PMX usage over time (especially for the very sick - as an alternative to death)----------------------------------"In severe sepsis, where every minute counts, no discussion on the role and effect of the time delay inherent in the trial protocol." Not part of the study - but clearly a justification for the use of the EAA ...and everywhere in the world IMO. Especially since it is an inexpensive way to determine who has a high level of endotoxins and who might best benefit from PMX. MM