Agreed, there are typically frequent discussions/calls with the FDA during these processes as well (which are not typically reported to the market). They are intended more for info requests and clarification etc. and not intended to update on the likelihood of clearance (like the mid-cycle review) but I would imagine that they would reveal some information. It is all a pretty standardised process, so I would imagine it is quite easy to be very confident in these things.
In other news, what a day! Not a massive gain (relative to the potential) but to break 10c is always a difficult task. Let's hope the green can be sustained throughout the week
BOT - Anything but charting, page-4067
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