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Wednesday, 09/11/2019 12:27:24 PM

Wednesday, September 11, 2019 12:27:24 PM

Post# of 423934
Whoa. Someone help me put some light to this. In the new faq they go into a little more detail on what was asked for in the sNDA.

“Not a replacement for statin therapy but as an incremental and separate prescription treatment option for patients at risk for CV events.”

Incremental AND separate prescription treatment option?

They are asking for on top of statin and stand alone?

This right here would be the main reason of the ADCOM.

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