We have been here before. FDA work on US time . All good.
So just a thought. Would it be possible that the FDA has indicated a preference to when they would like to see the BLA. You would think that someone there would be managing work load. Perhaps a particular person has been on holiday that would be part of there preferred review team. I don't think SI would necessarily file the BLA as soon as it was ready if he had been given a preferred date.
banter and General Discussion, page-10043
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