Hi Mugs, I'm fairly new to this board. If you could explain to me who this Dr. Polk is and what his credentials are I would appreciate it! I guess my biggest question would be, how does he know the FDA has now opened and viewed the images sent from Dean? Thanks.
Hey Mugs. Good to hear a little bit of good old rational thinking around here. I can't believe that so many are taking the fact that the FDA is actually into our file as a bad thing. Man, I have been following NEPH for over a year now and they didnt hear anything for over 12 months and then all of a sudden one day it their product is ruled as NSE. I don't expect that for IMGG but my point is companies go 12+ months with no correspondence which likely means the file was just sitting in the queue with no action until the the last 30 days or so. We neck deep in actual review 90 days in and folks are running around screaming the sky is falling. There are thousands of companies out there dying to hear the first peep from the FDA and Dean is exchanging phone calls and emails from them...a little something I like to think of as the home stretch.
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