Every single Mesoblast blinded controlled clinical trial has FAILED to achieve the primary end point. Every single one. The only trial that Mesoblast claims to have been successful was a small single arm open label trial with "theoretical controls" and a belated effort to provide group matched controls instead of individual matched controls. With no validated potency assay the FDA rightly said it was inadequate evidence of efficacy.
Infact the trial more closely resembled the previous phase 2 trial for the same treatment when it was called prochymal. Again an open label trial on 30 patients with aGVHD and a "promising" response rate.
https://ashpublications.org/blood/a...Phase-II-Trial-of-ProchymalT-Ex-Vivo-Cultured
But when it came to trying to replicate the results with a larger, blinded controlled phase 3 cinical trial it failed to produce the goods, not once but TWICE.
Novartis likely had a good look at the trial data for the Covid-ARDS trial that was stopped for futility and SI claimed was "successful. Then they walked away. Doesn't that tell you anything?
It's a crock.
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