Replies to post #115858 on Biotech Values

[DewDiligence]

AMLN—Was "Not Non-inferior" also "statistically inferior"? Was it also clinically inferior?

The answer to your first question merely requires statistical grunt work (which I have not done) and a few assumptions; the answer to your second question, however, is subjective.

Say, for the sake of discussion, that the non-inferiority margin in the Bydureon trial was 0.5%. I.e. Bydureon’s failing to achieve a finding of non-inferiority means that the “bad” boundary of the 95% confidence interval on the difference between the two drugs was a point where Bydureon was more than 0.5% worse than Victoza.

Is it clinically meaningful that Bydureon could be worse than Victoza by more than 0.5% with a probability of 2.5% or greater? I would say that it could be. Regards, Dew

p.s. The above shows why north40000’s post in #msg-60560038 is off-base; north40000 failed to realize that it’s the boundary of the 95% CI—not the difference in the means—that is the issue in this discussion.

[biomaven0]

Was "Not Non-inferior" also "statistically inferior"?

Conceivably - it was a very large (900 person) trial, so I guess it depends on the non-inferiority margin.

Weird result - Bydureon did much worse than in its other trials (1.3% vs range of 1.5% to 1.9% in its other five trials, and Victoza performed right at the top of its historical range.

Was it also clinically inferior?

Maybe not. Substantially less nausea/vomiting for Bydureon, and of course there is no need for a daily injection.

Can't see this affecting approval one way or the other, but obviously a serious hit for their eventual sales.

(No position in AMLN, but I do hold some Novo Nordisk).

[DewDiligence]

Adam Feuerstein botched the discussion of the Bydureon trial:

http://www.thestreet.com/story/11031389/4/biotech-stock-mailbag-to-dividend-or-not.html

…statistically speaking, Bydureon failed to demonstrate "non-inferiority" or equivalent efficacy. In plain English, the study showed Victoza works better at lowering blood glucose than Bydureon.

Wrong, Adam. Failure to show statsig non-inferiority is not the same thing as showing statsig inferiority.