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Re: BioChica post# 25552

Sunday, 02/23/2014 7:11:29 PM

Sunday, February 23, 2014 7:11:29 PM

Post# of 428881
Am I correct to assume that the CP denial and Vascepa's NP exclusivity decisions are related since they were pretty much determined on the same day? From the FDA's perspective, the CP denial should strengthen the case that Vascepa is not an NCE or Vascepa's non-NCE status should explains why the CP should be denied. However, when I read the reasons for the CP denial, it actually strengthens the case that Vascepa is an NCE. Is the FDA screw up or what?
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