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Re: Whalatane post# 110440

Thursday, 07/20/2017 1:26:18 PM

Thursday, July 20, 2017 1:26:18 PM

Post# of 430175
Kiwi - Good point. The company has said this and I believe the extra patient contacts are important for study retention and compliance. I was in a meeting last week where several FDA officials were present, and a high level person at one point commented on how hard it is to keep patients actively engaged in a "long-term study," and this was referring to months not years. CV trials may be a different animal though - all of the MACE outcome trials are very long, and maybe CAD (and high risk diabetic) patients have more reason to stay in a trial as the outcomes are literally life and death.
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