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Tuesday, April 08, 2014 6:51:57 PM
1.) increased script number - not expected before KOWA SF start their work
2.) SPA reinstatement (which is equal w ANCHOR approval, since CDER doesn't have a choice: all end point met, R-IT is significantly enrolled, so they have to approve it). I hope, but do not expect it from ODE II, however one level (or finally the court) has to reinstate it, since all real sciense / practice, other studies - sub-groups' data for the same target group (TG above 150/200), FDA's own reply (21 Jan) suggest that the theory (TG treating above 150/200 will reduce CVD) is good / promising.
FDA's statement - based on the 3 studies - that healty people (TG below 150) should not be treated is true, but ANCHOR is not targeting healty people.
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