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Biotech / Medical : Biotech Valuation -- Ignore unavailable to you. Want to Upgrade?

To: software salesperson who wrote (9565)	11/24/2003 12:54:56 PM
From: Biomaven	Respond to of 52153

From an investor's point of view, I'd much rather have a tough and predictable FDA than a FDA that is unpredictable. Historically I think there was something of an adversarial relationship between the FDA and companies. I think that's changing, and it can only be a good thing for everyone concerned. Note that a spirit of cooperation does not mean a capture of the FDA by those being regulated. Fortunately that hasn't happened in the past (despite Wolfe's whines to the contrary) and I hope it never happens in the future. (The obvious temptation to be avoided is for FDA regulators to "make nice" in the hopes of a fat job with a pharma or biotech company down the line.) One of the things that happened in 2001 was the FDA raising the safety bar in response to some safety issues that prompted a recall. That proved to be a disaster for investors - again it is the unexpected changes in standards that is the biggest problem. Incidentally I watched a Frontline report on the FDA recently. It was fairly biased, with airtime from Wolfe and also from an ex-FDA regulator now working with Redux plaintiff's attorneys. Of course they didn't stress the latter connection in their report. One good thing in the report was the focus on the inadequate post-approval surveillance by the FDA. In addition to Redux, the centrepiece of the report was the Aventis RA drug Arava. The issue there was sporadic reports of liver damage by this approved drug, but an AC meeting deciding that no response was needed. Turns out last week AVE sent a "Dear Doctor" letter. From the FDA site: Arava (leflunomide) Audience: Rheumatoid specialists and other healthcare professionals Aventis Pharmaceuticals and FDA updated the prescribing information for Arava (leflunomide), indicated for the treatment of active rheumatoid arthritis. In postmarketing experience worldwide, rare, serious hepatic injury, including cases with fatal outcome, have been reported during treatment with Arava. Most cases occurred within 6 months of therapy and in a setting of multiple risk factors for hepatotoxicity. Rare postmarketing reports of severe infections, including sepsis, which may be fatal, were also received. Most of the reports were confounded by concomitant immunosuppressant therapy and/or comorbid illness, which, in addition to rheumatoid disease, may predispose patients to infection.