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rfj1862

03/27/19 7:07 PM

#183715 RE: MNBioMike #183710

I was referring to as unprecedented was the fact that we haven't even submitted the sNDA for the R-It group that they've included in their SOC. Isn't that unprecedented?



No not at all unprecedented. The guidelines often front run the indication. For example for some beta blockers in heart failure the guideline recommendations came out well before their indications were expanded.

As I said before what is unusual and awesome is a Grade A recommendation right from the start. To me that makes it absolutely crystal clear that this is going to get the nod from the FDA. I would expect priority review as well.