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Replies to #37464 on Biotech Values
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DewDiligence

11/15/06 2:38 PM

#37465 RE: AlpineBV_Miller #37464

>Can you expand on what you mean by "not fully" versus "fully"?<

I used the phase not fully prespecified rather than not prespecified in order to allow for the possibility that some kind of Cox analysis different than the analysis actually conducted may have been mentioned in the 9902a protocol.
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poorgradstudent

11/15/06 2:46 PM

#37468 RE: AlpineBV_Miller #37464

As a general rule, the relevant, pre-specified endpoints are the ones that you hear companies talk about before the data are released.

The exploratory ones are the new ones that you hear about for the first time on the day of data release or months after the initial data are released.

At least that's the way I see it. If it was so important to a biotech's trial, they'd be talking about it before the data release.