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Biotech / Medical : Biotech Valuation

CRSP 56.98

+1.1%

Nov 5 3:59 PM EST

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To: Ian@SI who wrote (19384)	3/21/2006 3:37:55 PM
From: Biomaven	Read Replies (4) of 52153

Much as I grumble about the FDA from time to time, I think this bill would be a step in the wrong direction. I'm more sympathetic to the idea of a "Tier 1" approval for drugs like Iressa (my libertarian streak speaking here), but the prohibition on placebo-controlled trials is a mistake. It's important to note that some treatments might actually make things worse, so it's not clear that a treatment is always better than placebo. Trying to get a drug approved based on historical controls is a nightmare - we've seen plenty of examples of the dangers of extrapolating from historical controls in biotechland. But that's what would have to happen in diseases where there is no approved drug. Peter

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