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Biotech / Medical : Biotech Valuation
CRSP 56.51-1.5%10:16 AM EST
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To: scaram(o)uche who wrote (2309)12/15/2000 3:23:11 PM
From: Biomaven  Read Replies (1) of 52153
 
<MAXM>

Well it's very informative to do a post mortem and go back and read the following PR about a conference presentation of their study:

maxim.com

In particular:

In the primary population within the Phase III study consisting of all patients randomized into the trial with metastasis of the melanoma to their liver, multivariate analysis using the Cox's Proportionate Hazard Model adjusted for all significant prognostic variables or baseline characteristics demonstrated that treatment with the Maxamine combination significantly improved survival over the control arm (p=0.0017). The highly significant results of the multivariate analyses demonstrate that the significant improvement in survival reported for the Phase III trial did not result from differences in demographic or prognostic characteristics between the Maxamine and control arms of the study.

Now of course the FDA statistician came to a very different conclusion - basically that the Maxamine+IL-2 liver met group had many favorable prognostic characteristics (indeed reaching statistical significance) compared with the IL-2 liver met group, and this is what accounted for the apparently strong statistically significant (p=.0017) advantage shown by Maxamine.

Now in retrospect we can see that the key issue that torpedoed the study was that they did not stratify based on liver mets, as the FDA had suggested. I guess the moral here is that the next time someone comes with a subgroup analysis, ask whether they stratified the trial on that subgroup. If they didn't, no matter what the p-value, run for the hills.

Peter
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