Tuesday, December 14, 2010 10:16:07 PM
http://www.emergingcompany.com/volume14week47rdsl.ram
Just a few highlights.. Dean mentioned that they have hired a consultant group to readdress the application.. They have a firm strategy in place.. They have a law firm out of DC.. What they are going to do is repackage and clean up the format issues and present to the FDA on a call.. They are tired of this back and forward with all the questions.. If this isn't enough they want to know now so they can provide the needed info.. When they file they want a yes..
After they file the FDA has 90 days to respond..
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