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Biotech / Medical : Biotech Valuation -- Ignore unavailable to you. Want to Upgrade?

To: scaram(o)uche who wrote (2314)	12/15/2000 11:39:19 PM
From: Biomaven	Read Replies (1) \| Respond to 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

To: scaram(o)uche who wrote (2314)	12/16/2000 2:53:45 AM
From: Spekulatius	Respond to of 52153

My guess is that the liver met subgroup was not randomized because they didn't bet on this group before the trial started. They may have analyzed interim results and found that the liver met subgroup should statistical significance - but then it was too late to randomize this sub-group. Sort of dumb though to go with this data to the FDA and ask for approval.