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Biotech / Medical : Biotech Valuation

CRSP 56.87

-2.3%

Dec 5 9:30 AM EST

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To: nigel bates who wrote (7108)	9/25/2002 10:50:46 AM
From: Biomaven	of 52153

is it ethically possible not to approve the drug ? My answer is that it is not ethically possible to reject the drug. What the FDA's answer is remains to be seen. <g> Normally the FDA has three choices - reject a drug, approve a drug, or ask for more studies. Rejection is actually pretty unusual - the norm is that the FDA asks for more studies if they are not yet satisfied. But in this case another study that involves a placebo seems to me to be impossible. So the choice becomes reject, accept or do another non-placebo study that really isn't going to tell you too much. My prediction (assuming the mortality curves continue to diverge) is that the FDA will tell ITMN to go ahead with an NDA and then ask for an AC opinion. The AC will vote to approve, and the FDA will approve the drug. Peter

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