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pSivida Corp. Message Board

  • market_ace market_ace Nov 3, 2011 5:54 PM Flag

    Form 8-K filed - what does it mean?

    Does this imply that Alimera currently will receive an 'incomplete' grade on its Iluvien application with FDA -- until this study is finished? There's NO WAY that they have data from this September study yet. Is this old news or just an 'oops, forgot to tell you' from ALIM today?!!

    >>On November 3, 2011, Alimera Sciences, Inc. ("Alimera"), pSivida Corp.'s licensee with respect to ILUVIEN�, issued a press release providing the following information: "In September 2011, [Alimera] enrolled its first patient in a physician utilization study of its intended commercial inserter for ILUVIEN. The study was initiated in response to a request from the FDA to ensure physicians have a proper understanding of the instructions for inserting the ILUVIEN micro insert into patient eyes. [Alimera] has enrolled 54 patient eyes to date in this study, evaluating the safety and utility of the commercial version of the inserter for ILUVIEN, and is targeting to enroll 100 patient eyes before commercial launch." Data from this study may be required by the FDA for its consideration of the approval of ILUVIEN.<<

    full link: ht tp://biz.yahoo.com/e/111103/psdv8-k.html

    Appreciate any thoughts. I've been long PSDV for a while now.

    good luck -
    ace

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