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Re: oldcoach19 post# 27481

Monday, 01/08/2018 9:25:34 PM

Monday, January 08, 2018 9:25:34 PM

Post# of 30352
yes, I think it's 80 maybe 90% chance, looking at the Type C meeting from late 2016, the only issue brought up at that time by the FDA was the Human Factors study for the device, the good news there is that the company was not asked for anything else,

when you look at the presentation of their data on the latest corp presentation, it looks great,

the FDA has had no issue with efficacy or CMC, the safety data and studies are backed up by consistent feedback from over 1 mil doses given in EU,
and approvals now in 29 countries, those approvals are not easy to get,
I've seen many fail in the EU, combine that with the fact that the FDA under Trump is more willing to approve if the data is there, I'd say it will finally happen this time,

what do you think are the chances old coach ?
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