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pSivida Corp. Message Board

  • bernsteinjoshi bernsteinjoshi Oct 1, 2013 6:50 AM Flag

    The Drug Approval Process is funded by Industry and NOT affected by Shutdown !!!

    From $heff board you can find the link there :

    HHS: "FDA UserFee programs & available carry over funds paid by industry". That means that the PDUFA is pre-paid and not an added cost to government budget

    This is from Wiki :

    The Prescription Drug User Fee Act (PDUFA) was a law passed by the United States Congress in 1992 which allowed the Food and Drug Administration (FDA) to collect fees from drug manufacturers to fund the new drug approval process

    Sentiment: Strong Buy

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    • FALSE !!!!

      GOOGLE : Five FDA Approvals and Reviews at Risk Under a Government Shutdown

      By Jon C. Ogg | 24/7 Wall St. – Mon, Sep 30, 2013 10:35 AM EDT

      It looks like Congress and the president still cannot figure out how to play well with each other, and now we have another impending government shutdown. The reality is that some government offices will shut entirely and others would run on skeleton crews. You might not get government economic reports until things return to normal. One other big risk is the U.S. Food & Drug Administration. It turns out that several pharmaceutical and biotech drug candidates have pending FDA reviews in the month of October.
      In the first three weeks of October various FDA reviews are due for Pfizer Inc. (PFE) and Ligand Pharmaceuticals Inc. (LGND), followed by Antares Pharma Inc. (ATRS), Amarin Corp. PLC (AMRN), one for pSivida Corp. (PSDV) and Alimera Sciences Inc. (ALIM), and a final one for AMAG Pharmaceuticals Inc. (AMAG).

      pSivida Corp. (PSDV) has a review of ILUVIEN for the treatment of chronic diabetic macular edema (DME). The FDA accepted a resubmission of this from Alimera Sciences Inc. (ALIM) of the new drug application for ILUVIEN for DME, with a PDUFA date of October 17, 2013. Alimera has been granted marketing authorization for ILUVIEN for DME in six EU countries, and it already has began the commercial launch in Europe. Please note on this that a press relations person wanted to clarify as follows: "Alimera has licensed the delivery device from pSivida, and Alimera is the company that developed and submitted the new drug application for ILUVIEN to the FDA. pSivida has not been involved in working with the FDA on the review of ILUVIEN." pSivida has a share price of only $4.10, and a 52-week range of $1.17 to $4.28, with a market cap of only $95 million. Alimera trades at $3.72, with a $117 million market cap, and its 52-week range is $1.26 to $5.69.



      Sentiment: Strong Buy

    • lol bern

    • Keep it up for the uninformed people

    • bump

    • truth_is_the_mother_of_hatred truth_is_the_mother_of_hatred Oct 1, 2013 8:14 AM Flag

      Why do we wish it was funded by someone besides COMPETITORS Not that we want it funded by the government. There must be a better way. We're thinking of Mr. Tucker in the film "TUCKER" as we again realize the small drug companies with GREAT COMPETITIVE PRODUCTS &SERVICES are at the mercy of an agency funded by their competitors. Mr Tucker was way ahead of his time, but got shot down by the BIG 3

      Sentiment: Hold

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