Orexigen (NASDAQ:OREX) is looking at a PDUFA date of June 11 to find out from the FDA if it can bring its weight-control combo, NB32/Contrave (sustained-release bupropion/naltrexone), to market this summer. The major regulatory hurdle of FDA clearance for the US market is well known to provide a strong price movement whether up or down and in OREX's case it looks to be about 40-50% move either way. Does it work well enough to get that FDA nod? Is it safe enough for the FDA? Will it make appreciable sales once it does? Yes, yes, and yes.
FDA Reception Positive...
In December of 2010, an FDA advisory-committee panel reviewed Contrave's four Phase III studies and voted 13-7 that...
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