underrated post. In a pandemic when you know nothing about the disease or the progress of therapies or anything much at all, caution is warranted. I think we'll see some effect in the ARDS data, but not enough to meet their original trial design.
The downside is they would have had to power the trial with many more patients to get an effect at say 15%, which may have moved the endpoint to mid 20201 or longer, but that looks pretty enticing now that we didn't meet the ambitious 43% mark.
Ann: Remestemcel-L FDA Fast Track Designation for COVID-19 ARDS, page-563
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