Bio: Thanks for the reference. I am a believer that the NCE will be awarded when the mixed dyslipidemia indication is approved at year end. More often than not an NCE is granted at the time of approval. That said the precedence is based on "Presumption of Favorability" This is how all the myriad Insulin's, Low Molecular weight Heparin's, and Aminoacid's etc have been granted NCE's. Most recently Novo Nordisk had a new Insulin granted NCE status at the time of approval.
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