A fairly pointless argument when the ODAC is considering data from the Mesoblast trials and not the Osiris trials.
The other bizarre idea raised is that Mesoblast must have somehow designed a P3 trial without a Placebo control arm with nil input from the FDA, contrary to FDA best practice. When the trial was designed with FDA input, which is also why the 180 day data points were added on to the data collection, as a separate trial on ClinicalTrials.gov. The FDA wanted reasonable certainty on how many would live.
On that subject, worth looking at the data collection points for the Jakafi trial as we seem to be discussing it, i.e. out to how many days.
Ann: FDA Advisory Committee Sets Review Date for Remestemcel-L, page-165
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