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Monday, June 23, 2008 12:17:08 PM
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=28219061
http://www.fda.gov/cdrh/ode/idepolcy.html
My feeling has not changed and I think this process is supposed to be a more streamline approach by the FDA. However, I also view that the FDA is no different than any other government entity (red tape). It appears to me that whatever information the FDA wanted probably had to do with data in a real live setting.
Lastly, I think that whatever information/documentation that IMGG had to send them has probably been sent to the FDA (I don't know if this is true... just a hunch).
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