Biotech Stock Picking for Charity - 2006 Message Board

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Biotech / Medical : Biotech Stock Picking for Charity - 2006

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To: kenhott who wrote (411)	6/6/2006 11:16:14 AM
From: Arthur Radley	Read Replies (1) of 592

This weeks BusinessWeek has two interesting articles..the first titled: Going from the Lab to Limbo...The FDA has been delaying decisions on applications, and drugmakers are fuming. Basically, the article points out the growing risk-averse issues since the Vioxx debacle that the FDA is facing. All resulting in the growing "approvable" letters and not outright final approvals that companies need. They point out that since the beginnig of the year 10 such letters have been issued...examples being(Neurocine/PFE)..Indiplon, (Cephalon)..Nuvigil, (Encysive)..Thelin, and (Sanofi)..Rimonabant. As previously discussed here on SI, the article cites that the FDA didn't have enough time to review the Neurocine drug, thus only approving the two lower doses of the drug. The article goes on to point out that Cubist was actually in face to face meetings with FDA officials when they received notice that they had received an approval letter for the very drug they were meeting about. I guess this means the right hand does know what the left hand is doing at the FDA..so they merely issue approvable letters to delay making decisions.

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