You would think that these results would shine a favourable light on the aGVHD review. SI states that the hypothesis going into the trial was that it would reduce the severe inflammation which occurs in advanced heart failure and induce a small vessel network within the myocardium to protect the heart muscle against hypoxia and prevent death of heart muscle cells with the resultant scarring being a hallmark of heart failure. They reasonably assumed that the outcomes from such benefit would result in fewer hospitalisations. However the results are staggering.
Similarly with aGVHD and ARDS and I assume CLBP, the products are all anti-inflammatory and pro-vascular. I'm not a science person but surely there would be consideration by the FDA on the suite of products and the explainable reasons for their effectiveness???
I accepted the FDA's decision on aGVHD given the limited nature of the trial data and in particular the novel status of the treatment. They are not easy decisions to make and I stated on this forum that I thought the decision was prudent.
However I think that the same novel status should allow the FDA to consider evidence across all trials. The data is coming and the ARDS results will hopefully continue the body of favourable evidence. I fully understand why the SP fell on the news. However for me it was sweet music to my ears. The FDA are prudent and they will have my trust in the decisions they make. It's getting easier for them to say 'yes'. .
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