"My question to you is...where do you think we could be wrong? In other words, despite all the data and analysis done by people like you, where do you see the biggest unknowns...which would make you negative on phase 3 results?"

Like I said earlier, all this has been covered by myself and other in the past. BETonMACE is not a slam dunk.

Underpowered (only 2425 patients and ~260 events) resulting in p-value above significance threshold?

Too difficult of patient population (no diabetes drug has reduced MACE in clinical trial testing effect in diabetics with recent ACS)?

Minimal effect on 3-point MACE (as opposed to the softer additional two components of 5-point MACE) resulting in modest %RRR that does not impress?

Increased incidence of adverse events that makes NDA/MAA approval challenging?

Modest %RRR unattractive for approval due to adverse event profile?

Hepatic enzyme elevations problematic for FDA/EMA?

Significant MACE reduction only observed in rosuvastatin subgroup but not combined statin group?

Those are just a few ideas.....

BearDownAZ