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Sarepta Therapeutics, Inc. Message Board

  • biotechav biotechav Dec 4, 2012 11:18 AM Flag

    PSDV (Mcap $30 M) 3x Approved Drugs // Pfizer holds 9% // US NDA filing in January = 10 BAGGER POTENTIAL



    This undiscovered low float Stock will hit $7++ before FDA approval in 1H 2013 .PSDV will move into double digits easily with FDA approval for Blockbuster candidate Iluven for DME .There is NO FDA approved drugs for DME (Diabetic Macular Edema) a Blockbuster Market . Iluven is approved in Europe and Market launch will start during 2013

    Upon US approval of ILUVIEN, pSivida would be entitled to receive a $25 million milestone payment from Alimera and 20 percent of net profits, as defined, on sales of the drug by Alimera.

    DME is a potentially blinding disease that affects over one million people in the United States. Currently there are no FDA approved drugs for the treatment of DME.The U.S. market for DME is $1.5 billion to $4 billion.

    Psivida (PSDV)

    Market Cap: $30 M
    Cash: $17.65 M
    Price: $1.30

    Shares Out: 23.3 M ( Pfizer holds 1.9 M shrs )

    Alimera also announced that it intends to resubmit the NDA for ILUVIEN for DME to the FDA during the first quarter of 2013. Alimera further announced that using data from its two previously completed pivotal Phase III clinical trials, the resubmission will focus on the population of patients with chronic DME, the same group for which marketing approval for ILUVIEN has been granted in various EU countries. Approval in the U.S. would entitle pSivida to a $25 million milestone payment and 20% of net profits, as defined, from U.S. sales of ILUVIEN by Alimera.

    Our most recently approved product, ILUVIEN® for diabetic macular edema (DME), has received marketing authorization in the UK, Austria, France, Germany and Portugal, with approvals in Italy and Spain anticipated in the coming months. These marketing authorizations followed a positive outcome of the European Decentralized Procedure involving these seven countries. ILUVIEN, licensed to Alimera Sciences, Inc. (Alimera), is approved for use in the treatment of vision imparement associated with chronic DME considered insufficiently responsive to available therapies.


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