InvestorsHub Logo
Followers 1
Posts 145
Boards Moderated 0
Alias Born 01/12/2010

Re: Dr. Mugs post# 35194

Wednesday, 01/12/2011 12:41:52 PM

Wednesday, January 12, 2011 12:41:52 PM

Post# of 59550
After reading the NSE letter (thanks too, Sano), its become clear that the machine is nothing more than a rough prototype that is not, and never has been, anywhere near ready for a 510K submission, let alone an FDA clearance. There is nothing MWE can do to help expedite this through the FDA until all of the technical issues have been resolved. It would be another colossal waste of effort, time and resources for Dean to resubmitt at this point as the results would be the same. Instead of hiring lawyers, Dean's money would have been better spent if he had hired engineers to concentrate on debugging, rather than resubmission. But at this point, it appears that Dean's impulse has won out, and that will be costly indeed.