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Biotech / Medical : Biotech Valuation

CRSP 56.86

-2.3%

3:59 PM EST

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To: scaram(o)uche who wrote (2314)	12/15/2000 11:39:19 PM
From: Biomaven	Read Replies (1) of 52153

why weren't the liver met patients randomized? I assume because they had no reason to assume, prior to the trial that it would only work in liver mets, and each time you stratify further you make the trial more difficult to manage. The other complication here is that the trial (as I think you may have pointed out) was likely not really blinded given the histamine side effect (flushing). Negotiations with the FDA about the statistics look like they continued after the trial had been going for a while (and so maybe after they already had some clue as to the outcome), but at that point it was too late to start to stratify on liver mets. Peter

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