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Acusphere, Inc. Message Board

  • steve.higgins16 steve.higgins16 Dec 21, 2013 3:33 AM Flag

    Odds of approval

    I've been reading some articles from 2008 about the FDA panel reviewing Imagify and it doesn't look good. The FDA really slammed this product. We'll see what happens though.

    Is anyone really confident this will be approved in the EU?

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    • The FDA mid-hearing changed the criteria for approval from comparison of results to radioactive isotope testing, which Imagify based their testing on and demonstrated equivalence or better results, to wanting the tests to have been done as a direct comparison to ultrasound. Since radioactive testing had already shown superior results to ultrasound, Imagify should have been considered superior also. If Acusphere were to pay to reconduct testing versus ultrasound the FDA could reconsider approval. The radioactive isotope testing industry's exercised their influence on the FDA to get approval blocked. The EU may have more concern for the cost and safety benefits of Imagify and grant approval. The FDA may then reconsider a resubmision objectively, with less influence from the radioactive isotope advocates..

      Sentiment: Hold

      • 1 Reply to donsinma
      • Don,

        Thanks for your inputs here. Sounds like you are either in this business, or you have really been following ACAS. As I happen to agree with your logic, it confirms my persistence in hanging in there with my relatively modest position.

        But since ACUS is not the only biotech I have been burned by, I am somewhat reluctant to commit real money, until I see some more tangible evidence. For me, this would be a sign of money flowing in to ACUS shares at a sustained and elevated pace, possibly related to insider awareness of the prospects of approval, which would be reflected in some real money going in, not this nickel and dime stuff.

        It looked pretty good in September and October, when the 50-day MA crossed up through the 100-day MA, and about that time, I added to my position. But since then it seems to have died back down.

        Complicating the matter, about the only way you can successfully buy a block is to place a Market Order, which I am reluctant to chance, as with this thin market in ACUS, you can easily overpay substantially.

        Perhaps the best way to play this is to wait till buying volume picks up, perhaps inducing a bit of profit-taking, where you can place a limit order and actually get it off, albeit at a higher cost, but with substantially less risk.