Doc, I am the first to support objective debate, but you keep focusing on the "kids already improving". Too many up-rampers and down-rampers on HC get in the way of decent debate, but I think you are quoting a little out of context. Clearly they still showed a vast number of clinical concerns:
"While they showed some improvement in overall clinical status, many important clinical and laboratory parameters remained markedly abnormal, especially direct and indirect measures of cardiac dysfunction/injury (e.g., decreased LV function/need for inotropes; elevated levels of BNP and
troponin-I), systemic/cardiac/endothelial inflammation (e.g., elevated levels of C-reactive protein, procalcitonin, ferritin, and total white blood cell count), and endothelial dysfunction (e.g., hypotension/need for vasopressors; elevated levels of D-dimer and fibrinogen)".
Its only two patients, but Remestemcel-L addressed these elevated markers and the kids were then discharged. Put all the anecdotal, secondary endpoints, bio-marker data etc together and it starts to make a pretty compelling picture. Of course MSB did not pass primary endpoint requirements, but the data, THAT WAS PRE-SPECIFIED, showed significant promise, as yet again do these, admittedly anecdotal, cases.
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- Ann: Remestemcel-L for COVID-19 MIS-C published in Pediatrics
Ann: Remestemcel-L for COVID-19 MIS-C published in Pediatrics, page-181
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