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Wyeth Warns on Drug Delay--and Confuses Investors

This article was originally published in RPM Report

Executive Summary

It isn't getting any easier to interpret the significance of FDA's decisions to schedule--or skip--an advisory committee meeting. Wyeth CEO Bob Essner made that task all the more difficult when he alluded to a new policy at FDA requiring advisory committees for all psychiatric drug products. FDA says there is no new policy, but Wyeth's antidepressant desvenlafaxine is likely to face approval delays for another reason altogether: manufacturing problems.
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