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mr_sano

04/28/11 11:42 AM

#41559 RE: Woodberry578 #41558

Woodberry>

Heres what you posted in Jan form the SH meeting. Would you concede that Deans is again stretching the truth?

<Dean is optimistic the new resubmittal will happen by either the end of February or March (I would not hold Dean to these specific dates. Remember: it is his best "guess-ta-mit"). The resubmission will be proceeded by a face-to-face meeting with the head of the FDA's Medical Devices unit and our FDA reviewer. ]On the Imaging3 side of the meeting, Dean will be there, Jim Cohen (lead attorney at MWE), and our Consulting Firm's Technical writer.[/b The goal is to iron out key points needed to gain FDA approval once the new 510K is submitted. Again, the impression I got is: Dean is hopeful of a June answer from the FDA (again, an estimate on the timeline).>
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Not a Pumper

04/28/11 12:35 PM

#41566 RE: Woodberry578 #41558

Okay Wood. Thanks for your input.

From the outside looking in, it's concerning that Dean hires one of the top firms out, MWE, and then dumps them after 3 months and abruptly switches strategies. I can't seem to wrap my head around why he'd let them go other than to argue they were just too expensive.
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Dr. Mugs

04/28/11 12:50 PM

#41571 RE: Woodberry578 #41558

Woodberry578... A poster asked you on 3/24 if MWE was still on board and when was the last that you heard. You responded "About 2 weeks ago, when I spoke to Mike Nessen". Post#39485 So, It is very clear that Mike Nessen, an officer in Imaging3 was not telling the truth since MWE was long gone by then