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Mylan N.V. Message Board

  • chart2001 chart2001 Feb 6, 2012 3:00 PM Flag

    must read

    Needham & Company maintains a 'Strong Buy' on Mylan (NASDAQ: MYL) price target of $29.00.
    Analyst, Elliot Wilbur, says, "In the fast and furious world of paragraph IV patent challenges, he who files first usually steals the show. However, given the unprecedented backlog of generic applications sitting at FDA and the dramatic deceleration in approval times, we are encountering more situations in which generic first filers, through no fault of their own, are increasingly at risk of losing 180-day exclusivity because they are unable to secure tentative approval within the 30 months of filing. This possibility is certainly worth pointing out with respect to generic Lidoderm, a product in which only two generic filers have emerged to date 'Watson (N&YSE: WPI)(Hold) and Mylan. Watson has received all the attention of course because of its first-to-file status, a favorable outcome in early litigation proceedings, and the approaching 30-month window expiry. Watson management, in response to commentary from Endo (Nasdaq: ENDP)(Hold) counsel in a court document suggesting that a bioequivalence study issue could delay Watson s approval, reaffirmed prior commentary that it fully expects to receive tentative approval by July 15, the 30-month stay expiry."

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    • what would be bigger plus for Mylan would be if there is really an issue with watson's biostudy then an arguement could be made that watson is not first to file since it was not a complete filing then mylan would be first to file on an approximate 1.0b product.

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