A Transparency Case Study: Horizant Approval for RLS Offers Window Into Complexity of Complete Response Disclosures
This article was originally published in RPM Report
Executive Summary
The rejection of XenoPort’s restless leg syndrome therapy in February 2010 shocked investors, and so did the April 2011 approval of the application after a nifty piece of regulatory re-engineering by the sponsors. Would public release of the CR letter have helped investors handicap the prospects? That seems unlikely in this case.
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