Does anyone understand the implications of No EIR (Establishment Inspection report) announced?
As per FDA rules, tThis must have been announced at least 3 weeks before PDUFA date.
So, no anouncement means it's positive? is EIR mandatory to be notified to the inspectee?
Is Mesoblast liable to announce the receival or report to ASX as per law?
In case EIR is delayed, can it be an indication of possible delay in PDUFA date?
As we get closer, more unexpectedly missing things create anxiety.
all valid questions.
Does anyone understand the implications of No EIR (Establishment...
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