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Re: rafunrafun post# 104909

Monday, 04/24/2017 1:47:26 PM

Monday, April 24, 2017 1:47:26 PM

Post# of 429056
Raf - I think they are trying to do an amended ANCHOR application to expand to lower TG levels, and since the original application proposed a TG-based cutoff, they have to stick to the same thing in the amended application. They are giving the FDA the study they asked for (R-It) to address data deficiencies in the original application.
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