Just chasing some opinions (not from whytee or mcstuffin)
the only thing that concerned me was as per the highlighted below around ongoing discussions with the FDA (not for the sake of not being approved but more so in relation to possible delays/minor items needing fixing up in re issuing a CRL). I would have thought in this late stage (2 days before approval) the discussions would have finished but they have said it in the present tense…I’m probably just jumping at shadows…is this just a throw away line that they have used previously and maybe just copied and pasted?
Just chasing some opinions (not from whytee or mcstuffin)the...
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