With remestemcel not approved for AGvHD, there was no way FDA were going to approve it for anything else (including Ards) until the outstanding issues are resolved/agreed. It all comes down to the OTAT meeting but my biggest question is what are the timelines from that meeting?
Is it a month for the OTAT meeting minutes, a couple of months to lodge a request for another FDA meeting, another a couple of months to have the meeting and get the minutes?
This could easily be another 6-12 months to get an outcome on remestemcel and I'd expect NVS will stay on the sidelines until then.
With remestemcel not approved for AGvHD, there was no way FDA...
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