One thing to remember @Bazsa is that we were notified on 13 Dec 2018 that Mesoblast had a meeting with the FDA about aGVHD so the 60 day lead time may have started then; then of course they had the longest government shutdown in USA history so that would have caused issues ? I think as you say they will get the notes from the meeting within 30 days, which hopefully confirms what was discussed and they can submit the first part of our BLA .... shouldn’t be long now
GLTAH
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- Ann: FDA Agrees to Rolling Review of Mesoblast BLA Submission
Ann: FDA Agrees to Rolling Review of Mesoblast BLA Submission, page-72
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