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Biotech / Medical : Biotech Valuation
CRSP 55.11-2.6%Nov 7 9:30 AM EST
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To: Icebrg who wrote (19680)4/7/2006 7:17:24 PM
From: A.J. Mullen  Read Replies (1) of 52153
 
I talked with someone with a lot of experience in (British and American) clinical trials about this case. One thing he said was that the sheer weight of paper works tends to make people stop thinking. "As long as all the boxes are checked, there's a feeling that it must be safe." Too much faith in the system.

He explained that administration of drugs is not staggered because the effect of circadian rhythm would complicate analysis unless separation was by days and that takes more time and money. But in phase I, how much analysis is necessary?

On second thoughts, Phase I is usually about looking for more subtle effects than those found with TGN1412. MAybe there will be a call for a prior phase that just checks patients continue to breath and talk. That could be staggered, which would mean one emergency, not half a dozen.

Ashley
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