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VuBru

09/11/19 5:53 PM

#213834 RE: MNBioMike #213829

MNBio - It has to do with the scientific issue called "generalizability." Basically, you cannot apply results from a study sample (e.g. showing V-related MACE reductions) to a population that is different in key characteristics from that study sample. No one in R-It was statin-free, so you cannot generalize R-It results to people not on statins. Not saying V alone would fail, but the FDA would have no proof of this yet to justify a statin-free label.

dmlcento

09/11/19 6:51 PM

#213856 RE: MNBioMike #213829

MNMike, what post has Amarin's response to you?

Comber

09/11/19 8:51 PM

#213880 RE: MNBioMike #213829

I take repatha and this. Has done wonders