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JAA106

11/08/10 2:49 PM

#31708 RE: Denunzio36 #31706

I am speaking from experience, I live in Maryland just 90 minutes from DC. Corruption and back room deals is the way it is.
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SirBigWill

11/08/10 2:53 PM

#31710 RE: Denunzio36 #31706

I will never discount the "government corruption" angle, but I have to admit that I became very concerned when I heard the file was 1200 pages thick. Then I learned that it included all of the previous review team's questions & it was in such an incoherent format that Dean decided to send a new one replete with annotations. I believe the FDA had sufficient grounds to reject the application if it truly was a "mess" & missing financials.

I hope the consultants will clean it up & fill in all the blanks. At that point the FDA should have no problem granting SE. Until then, as sad as it is for my stock account, I have to agree with the decision.
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mr_sano

11/08/10 3:00 PM

#31711 RE: Denunzio36 #31706

Conspiracy theories...guys this was rejected for good reason. Likely because it uses a different control system that the predicate. Just because you have a a commercially available emitter and detector doesn't mean the control system to make this work safely is "off the shelf" Hardly Deans patent makes several references to indexing. How this is accomplished and how the software pulses the emitter along with safety controls is the key questions. The whole "GE is behind this" demonstrates the undying loyalty Dean has developed from his followers. I think this will be undone shortly within 60 days.