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Re: Denunzio36 post# 31706

Monday, 11/08/2010 2:53:11 PM

Monday, November 08, 2010 2:53:11 PM

Post# of 59551
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.