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Re: DewDiligence post# 36659

Tuesday, 10/31/2006 5:39:51 PM

Tuesday, October 31, 2006 5:39:51 PM

Post# of 257677
Torcetrapib lipid results are fairly impressive but a CV drug that raises BP, hmmm....not good. I would not like to predict the outcome studies. I recall VIOXX raising BP about the same!

The lipid results are meaningless. The reason HDL is not an approvable endpoint is you can raise HDL without generating an improvement in morbidity and mortality. It's why the EU and probably the US will wait for morbidity and mortality data before approval.

As we've discussed here before, I believe that the size of the trial might make the results statistically significant based on the law of large numbers, but they are unlikely to be clinically significant.

The IVUS data is expected in March, but the hard endpoints won't be ready until 2008 or 2009. Ironically, the best Pfizer can hope for is that the torcetrapib trials validate a faster way to market for competitors by confirming the IVUS data we see next spring.

Unless otherwise indicated, this is the personal viewpoint of David Miller and not necessarily that of Biotech Stock Research, LLC

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