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Replies to #41665 on Biotech Values
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fid

02/07/07 10:30 AM

#41667 RE: fid #41665

The drug doesn't have to reduce death in 30 days to have a meaningful benefit. Reducing non fatal mi is all it needs to do. As long as it doesn't increase death, which it shouldn't.


Your statement seems to be at great odds with the following, any thoughts?

http://circres.ahajournals.org/cgi/content/full/95/2/125

It is important to note that FDA approval requires improvement in morbidity and mortality; secondary end-points such as limitation of infarct size are not sufficient.

fid

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iwfal

02/07/07 2:28 PM

#41682 RE: fid #41665

To repeat the results, the Alexion trial was in fact statistically significant in reducing non fatal mi and did not reduce death in 30 days which you said it doesnt have to do.

Not exactly fair - Alexion's PRIMO-CABG did show a meaningful reduction in death, but the total number of events was too low. FWIW.

Clark