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Biotech / Medical : Biotech Valuation

CRSP 56.87

-2.3%

Dec 5 9:30 AM EST

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To: scaram(o)uche who wrote (2336)	12/18/2000 5:44:59 PM
From: Biomaven	Read Replies (1) of 52153

Rick, In the Maxim case we had an underwritten offering (actually two if you include their merger) where FDA disagreement was not disclosed. If the well-funded underwriters, with their necks on the line, can't do a decent job then I doubt that an external agency or organization could either. What of course would work is for the FDA communications with a company to be made public. I've always wondered what you could get out of the FDA with a FOI request on a pre-approved drug. On Maxim specifically, there might well be substantial liability - it's not an open-and-shut case, though. Lots of companies have disagreements with the FDA on trial design, labelling, etc. I doubt if the company carries anywhere near enough insurance to cover their potential liability, although the underwriters might end up footing part of the bill. Peter

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