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pSivida Corp. Message Board

  • liberal_nation liberal_nation Feb 1, 2013 4:19 PM Flag

    Since You Asked


    PSDV is a good company with a fairly good track record of success.
    I played the Iluvien run-up going into the November 2011 CRL.
    Management does not seem upbeat about approval without the
    additional phase III trials "requested" by the FDA. It is folly to believe
    that the FDA is inclined to approve just because they accepted the NDA
    for review. Just take a look at the four CRLs DSCO's Surfaxin received
    before finally gaining approval. Then, there's dear old HEB. How many
    times has Ampligen received a CRL. The drug has been around since
    the 1960's. It's been applied to every trendy malady to come along from
    HIV to Chronic Fatigue Syndrome, and still no approval. Ampligen has
    a PDUFA of February 2nd. It will be yet another CRL. I just dropped by
    to see what was moving the stock. It's on one of my watch lists.
    I hope the reformatted data will win over the FDA, but, in my experience,
    that rarely happens.

    This topic is deleted.
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