Friday, August 20, 2010

Jazz Pharmaceuticals (JAZZ) - unfavored by FDA panel for JZP-6 approval

Today's FDA advisory panel meeting marked a bitter wind down for Jazz Pharmaceuticals (at least before the PDUFA).  The votes were 20 NO vs. 2 YES for recommendation of JAZZ's late stage drug, JZP-6.  A minute-by-minute coverage of the panel discussion can be read here.  This outcome was broadly unanticipated and once again underscored the unpredictability of the FDA.  Of note, the FDA, while almost always, does not have to follow the panel's decision in passing a drug for marketing.  This may leave a razor thin glimpse of hope for the troubled firm and its investors.  Based on my trading strategy, readers were advised to exit between Aug 13-17 without holding positions through the panel.  Those who followed, myself included, enjoyed a handsome return from the smooth (20-30%) pre-panel runup (from ~$8.50 - $11) despite the unexpected tragic ending.

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