Encysive, the FDA and the Dispute Resolution Process
Forbes recently had an article on fighting the FDA.
You Can’t Fight The FDA - Forbes.com
I have been watching this drama play out for sometime now and for me it is like watching a train wreck. You know what’s going to happen, you know it isn’t going to be pretty but there’s nothing you can do to stop it from happening. I’m not sure I understand Encysive’s rational for going through this dispute resolution process as it seemed doomed from the start.
Eye on FDA mentioned this in the Weekly Roundup - 9-7-07 and had a great article on this situation earlier: Eye on FDA: What’s at Stake with Formal Dispute Resolution
Other recent articles on this.
Encysive Pharmaceuticals Investor Relations
FDA: Encysive Drug Not Effective Enough - Forbes.com
PharmaLive: Encysive Pharmaceuticals Receives Written Response From FDA On Its Request for Formal Dispute Resolution for Thelin (Sitaxsentan Sodium)
Other Sources
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Technorati Tags: Encysive, Thelin
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