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Wednesday, July 18, 2007 6:03:08 PM
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).
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).
“The efficient-market hypothesis may be
the foremost piece of B.S. ever promulgated
in any area of human knowledge!”
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