Biotech Values

[DewDiligence]

Re: BG-12 vs Copaxone

even if the trial was not powered to determine superiority over copaxone, if BG-12 would have "beat copaxone with ease", then it would have been statistically superior. It obviously was not as it was not included in the PR.

I agree in part. If BG-12 had been statsig better than Copaxone, BIIB probably would’ve said so informally on today’s CC; however, I don’t think BIIB would’ve included such a statement in today’s PR because it’s not kosher to make a post-hoc assertion like that and the CONFIRM study was clearly not intended to test BG-12 against Copaxone directly.

Putting aside the negative CC inference for the sake of discussion, I can’t tell from the numbers themselves whether BG-12 would have been statsig better than Copaxone on the primary endpoint of ARR if such a test had been performed. I doubt that it would have been, but I’m not sure.

On the secondary endpoint of % of patients who relapsed, I’m pretty sure BG-12 would not have been statsig better than Copaxone if such a test had been performed.

In any case, jbog clearly jumped the gun by proclaiming in the header of his post that “BG-12 beats Copaxone with ease.”

this means they are equivalent in my book.

Here, I don’t agree. The fact that BG-12 was not statsig better than Copaxone in the CONFIRM study does not mean that BG-12 isn’t better. Lack of proof of superior efficacy is not the same as proof of lack of superior efficacy. Regards, Dew