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Re: None

Wednesday, 07/18/2007 6:03:08 PM

Wednesday, July 18, 2007 6:03:08 PM

Post# of 2446
Additional color on I-vation from the CC:

1. MRK might opt to run a pivotal phase-2/3 trial of I-vation TA in place of an ordinary phase-2.

2. It has been determined that I-vation products will be treated by the FDA as drugs, not devices. I.e., the FDA group responsible for review of I-vation is the Division of Anti-Infective and Ophthalmology Products (DAIOP).

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