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Re: DewDiligence post# 1428

Wednesday, 07/18/2007 8:29:00 PM

Wednesday, July 18, 2007 8:29:00 PM

Post# of 2446
Re: I-Vation

Treated as drugs, not devices? Perhaps this is because the device is easily removable? I hope this would accelerate the review process.

Pivotal phase II/III: if enrollment were to begin soon, it would put I-vation TA not too far behind Medidur (currently enrolling phase III), although I believe Medidur has FDA fast track status. I wonder whether Medidur is also treated as a drug by the FDA?

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