banter and General Discussion, page-11381

si said something like lots of backwards and forwards with fda. lots of questions. very good to be in active dialogue and thats a good thing when you're under submission review. '
they must getting questions they can answer and if the questions they're getting relate to late stage clarifications then it its a really good thing.
if they were getting questions about clinical data, biomarkers and assays and in vitro vs in vivo and single arm trials and endpoints and batch to batch variability that wouldn't be a good thing.
so maybe they are talking about labelling or post marketing commitments. questions they can easily answer which gives him enough optism to say the decision could possibly come a little bit sooner . especially because much of the review was completed last year, in particular the manufacturing inspection.