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Biotech / Medical : Biotech Valuation

CRSP 55.11

-2.6%

Nov 7 9:30 AM EST

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To: quidditch who wrote (7106)	9/25/2002 9:26:24 AM
From: Biomaven	Read Replies (3) of 52153

quid, McClellan would be very good news indeed from my perspective. Someone I know that has worked with him describes him as "brilliant" and speaks very highly of him. Even more important, he brings an economist's perspective to the FDA - he's someone who understands cost-benefit analysis and should be prepared to stand up to the bureaucrats and nit-pickers. On your second question, I don't think the Iressa panel has any relevance to Actimmune. These panels don't set general policy - they are focused entirely on the drug before them. Ultimately I think the FDA will approve Actimmune without a new trial, particularly if the mortality advantage continues to widen as the trial continues in an unblinded form. The key issue is that a new trial is ethically impossible - a similar trial in mild-to-moderate patients would be statistically expected to kill about 15 people in the placebo group. So the FDA can't reasonably ask for a new trial, and needs to make a decision based on the existing trial. Peter

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