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DewDiligence

08/01/11 1:04 PM

#124222 RE: biomaven0 #124221

I'm assuming they didn't stratify with respect to all possible variables.

If a baseline variable is deemed consequential to the outcome of a pivotal trial, the sponsor has two options: i) stratify the arms according to this variable; or ii) make the primary endpoint a (pre-specified) Cox regression analysis that includes the variable in question. In the BRAVO trial, Teva did neither of the above, and therein lies the problem.

Based on today’s share price, investors evidently didn’t buy the doublespeak in Teva’s PR.
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jq1234

08/01/11 8:01 PM

#124223 RE: biomaven0 #124221

It's worth noting that Avonex also didn't beat placebo in the non-adjusted comparison, but did so after adjustment.



Are you talking about BRAVO trial? If you do, it is not ture.

Avonex also significantly reduced ARR both before and after adjusting for baseline MRI dissimilarities vs. placebo (0.26 and 0.27, respectively).

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mcbio

08/01/11 11:09 PM

#124232 RE: biomaven0 #124221

The interesting play here might be the Swedish company Active Biotech (NASDAQ OMX NORDIC: ACTI) which was down very sharply indeed.

Looks like ACTI was down over 50%. I assume your initial thoughts here on ACTI have changed as a result of the follow-on discussion regarding the Avonex results beating the placebo. If not, curious to hear more on why you think ACTI may be an interesting play.