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Message: Re: My guess is a second BTD is coming

"But would they need to do much for the CHF in place of Stroke, seeing that the secondary BOM endpoints resulted from 2400+ patient population?"

Koo, BETonMACE failed its primary endpoint. Yes, many secondary endpoints, including CHF, look amazing. And yes, reduction of the primary endpoint in pre-specified (i.e. CKD) and non-pre-specified (i.e. SGLT2/DPP4 inhibitors) populations look amazing. However, none of this changes the fact that BETonMACE failed its primary endpoint for the whole population. This is typically the metric for success or failure of a trial.

Your statement suggests that you feel it is a given that apabetalone will be approved based on BETonMACE alone. It is far from a given. Possible, yes. Likely? In my opinion it is more likely that further clinical development will be required prior to approval. Very unusual for a drug to be approved after failing its first Phase 3 trial. Many drugs require passing at least two Phase 3s prior to approval. Possibilities vs. Probabilities.

BDAZ

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