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GlaxoSmithKline plc Message Board

  • biotechking10 biotechking10 May 24, 2011 6:53 AM Flag

    ot) Blockbuster Drug approval in 2H11(Mcap 80 M) =Multibagger Potential

    Dont miss the BIG RUNUP before FDA decision .....


    This low float Stock will hit $7++ before FDA approval in 2H11 .PSDV will move into double digits easily with FDA approval for Blockbuster candidate Iluven .There is NO FDA approved drugs for DME .

    PFIZER holds 10% or 1.9 M shares bought at ~$10 per share they are the largest shareholder in PSDV !!! GLTA


    Psivida (PSDV)

    Market Cap: 81 M
    Cash: 23 M
    Price: 3.90 $

    Shares Out: 20.7 // PFIZER (PFE) owns 1.9 M



    pSivida Corp. On Friday May 13, 2011, 8:31 am EDT

    pSivida Corp a leader in developing sustained release, drug delivery products for treatment of back-of-the-eye diseases, today announced that its licensee, Alimera Sciences, Inc., resubmitted a New Drug Application for the investigational drug ILUVIEN® for the treatment of diabetic macular edema (DME) to the U.S. Food and Drug Administration (FDA) on May 12, 2011 to address questions raised in the Complete Response Letter (CRL) Alimera received in December 2010.

    Alimera reported that according to the FDA’s classification scheme, this will be a Class 2 resubmission. Under the Prescription Drug User Fee Act (PDUFA), FDA review of a Class 2 resubmission is expected to be completed within a six-month period beginning on the date that the resubmission is received.

    Upon 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.

    ..............................................

 
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