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Re: None

Friday, 04/04/2008 3:49:54 PM

Friday, April 04, 2008 3:49:54 PM

Post# of 59551
Link for FDA - CDRH: Guidance on IDE Policies and Procedures.

http://www.fda.gov/cdrh/ode/idepolcy.html

Lots of information here regarding the process. I took a good look at the area of 'Interactive IDE Review'. It appears to me that this process involves a continuous contact with the Office of Device Evaluation (ODE), "rather than only at the completion of the review, deficient information can be addressed within fewer review cycles."

If I'm reading this right, I think this stock is way under valued! This interactive process appears to be a big advantage to Dean & Company towards getting the Dominion to market, sooner rather than later... (jmo)



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