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Atom0aks

11/10/19 11:08 AM

#224040 RE: rafunrafun #224038

A - so your logic for a 'no primary prevention' vote is because the primary prevention subgroup did not show statistical significance?

If so, do you realize that the trial was not designed to show statistical significance for this subgroup?

It's like saying that RRR for >65 year olds was only 13%, therefore the label should not include anyone who is older than 65.



I do realize that. As VuBru pointed out, REDUCE-IT has two populations. I am predicting the AdCom is only focused on one of them, which could go badly based on history. Overall, I still think there is the potential for a label with the second population.