The FDA approval is for a specific application. The EUA for Covid and the BLA for aGVHD are two separate applications. The OTAT is assessing the resubmission of the BLA for aGVHD, not ARDS. Perhaps since the covid emergency has subsided relative to the expectations during the initial phases of the pandemic NVS have realised that there is not a significant opportunity for them to continue with the Covid/ARDS partnership. The outcome of the OTAT has no bearing on the ARDS trials. None, separate data sets. Do you think they have considered the data for the aGVHD trials in the ARDS applications? Why run trials at all then? Just proof the therapy and say use it for everything.... that's not how it works.
OTAT Meeting, page-12
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