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Re: srinsocal post# 87172

Monday, 10/24/2016 1:16:39 PM

Monday, October 24, 2016 1:16:39 PM

Post# of 333753
Makes all the sense in the world, doesn't it, SR? For the life of me, I can't see any other reason for those numerous meetings between FDA and BIEL except for getting on the same page for ironing out some details. Most likely, IMO for package wording of disclaimers, restrictive areas of use and warnings. I also feel they have finally provided the FDA with, what I believe to be enough case studies, by the submitting of the Oxford trial data and the FDA acceptance of UK real world data. The "OK" will come quick and without warning, so sitting on the sidelines could be a serious regret. Personally, I am adding at every opportunity.