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What: Shares of pharmaceutical company Impax Laboratories (NASDAQ:IPXL) plunged as much as 26% after announcing an update on the Food and Drug Administration's inspection at its Hayward, Calif., facility for its idiopathic Parkinson's drug, Rytary.
So what: The FDA's findings from its pre-approval inspection and good manufacturing practices inspection revealed 12 points of concern -- three of which were repeat violations that the FDA had issued concerns about in a warning letter in 2011. Unfortunately, this would appear to pit Impax and the FDA much further apart than investors had first thought with regard to the number and scope of manufacturing deficiencies discovered. Brokerage firm Canaccord also downgraded Impax on the news from "buy" to "hold," adding insult to injury.
Now what: This really is a shame because Rytary has shown plenty of promise in trials, and there's little question about its efficacy. However, two complete response letters later and Impax still can't seem to get things right. One possible scenario could see the company sell its entire rights to Rytary to international licensing partner GlaxoSmithKline (NYSE:GSK) -- if it wereinterested that is! While this scenario is a long shot, it's pretty clear Impax has no clue what to do to bring Rytary to market, and it can't be completely discounted. The other scenario is Impax will trudge along, make the appropriate fixes, and perhaps in nine months to a year we'll see if the third time is the charm.
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