FDA Issues Third Approvable Letter to Encysive for Thelin
Encysive may have set a new record for the number of approvable letters for one single product. Recently the FDA gave them their THIRD approvable letter for the product Thelin (sitaxsentan sodium)
Press Release: FDA Issues Third Approvable Letter for Thelin - FierceBiotech:
TheStreet.com has an insightful article on this.
How Encysive Botched the FDA Game
I won’t recount the history since TheStreet.com article does an excellent job. I think companies need to keep in mind that demanding a formal review after all that has happened seems desperate at best and bull0headed at worst.
This failure has led Encysive to have massive lay-offs.
Encysive to lay off most of U.S. employees
Encysive slashing 150 jobs
If you want to listen to the companies webcast on this it can be found here.
Other Resources
encysive thelin - Yahoo! Search Results
encysive thelin - Google Search
encysive thelin - Google News
Yahoo! News Search Results for encysive thelin
Google Blog Search: encysive thelin
IceRocket Blog Search: encysive thelin
Technorati Tags: Encysive, sitaxsentan sodium, Thelin
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