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Message: Meaning of MACE in the BTD

Golf - Aplogies for being so slow to answer your question! Somehow I missed it.

I don't think the FDA would approve a drug for anything that has not been tested in a clinical trial. So imo it would probably only be for the prevention of MACE in patients who conform to the selection criteria of BETonMACE. Still a very big market. 

Anything beyond that (eg primary prevention of CVD in type 2 diabetics) would need to be supported by another clinical trial that specifically addressed that question. That would be a big undertaking, but as it would be hugely lucrative if positive, it's not impossible that a BP would take it on.  

 

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