I tried to add something intelligent to your post, but after a few hours I concluded that standard was too strict!
I also think it is death benefit that is contributed by the valve group, but for different reason: due to Bell’s emphaisis on “consistency” claim, as P2 valve obviously—-I say obviously but we were never told--did not contribute any MI saving.
If it is death in valve that is the overall population’s saving grace, and if in CABG-only there are 2 trials with strongly “consistent” reductions in severe MI >100ng/l, plus “many key secondary endpoints” met in 300 pt trial, why would a doctor not use this drug in every CABG procedure? Those adverse outcomes, the key secondary endpoints (death, stroke, MI, cardio shock, neurocog decline, whatever?), sound clinically meaningful to me.
It goes to question: what was proven?
As soon as you and I take data from valve group and try to drop it into CABG, we are already answering the key question, aren’t we? ie, Does the significant larger trial “prove” anything? If we can use the valve data to interpret CABG, or if we use CABG to understand valve aren’t we accepting the valve data? If it is legitimate to do this then it looks to me like pexeli ought to be approvable and will be widely prescribed.
But this is what I do not understand. If adding the valve group is not at all statistically legitimate to prove drug’s therapeutic advantages, then the market has been too kind to the stock and I am seriously delusional.
Looking way too far ahead, Would FDA approve the drug based on significnace in CABG+valve group and limit label to valve? I can't believe that would happen. If label is based on larger trial, what would restrict pexeli's use? If final conclusion is it saves lives in sick patients and saves heart attacks in well patients, then it looks like a success to me. |
