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InVivo Therapeutics Holdings Corp. Message Board

  • jsteveco730 jsteveco730 Jan 29, 2013 10:01 AM Flag

    anyone able to confirm if FDA news is out yet?

    Today may be the day

    Sentiment: Strong Buy

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    • If you read the HUD guideline it says they will respond and in that response it could be YES NO or Need more info. So saying Today is the last day or tomorrow is not true. This HUD submission is not the same as getting Human Trial approval. I personally am on board for the long run and the HydroGel anything from the device is a bonus to me.

      Sentiment: Strong Buy

      • 1 Reply to a1ag
      • Hi a1ag. I believe while you are correct on there being 3 choices, the more likely would either be a yes or a "need more info" and not a flat no. My reasoning on this has been illustrated on this board: In their meeting with the FDA, it was *agreed* that this would be the pathway to pursue. Any disqualifying "no's" would have prevented this "agreement in principle" from the outset. So, it should either be a yes or be a " look guys we want to say yes but we need a little more info." I hope it isn't the later because another delay would be painful. I am really hoping it will be a straight "yes" because that should also kick the IDE request some juice. That being another critical item that is expected fairly soon.

        Sentiment: Strong Buy

    • If the news was out yet, the volume would be very heavy and the price would be moving up or down dependent on the news.

      Not holding my breath - I think when the news come, the press release will come after market close.

      Also - we'll likely see strong volume action towards the end of whatever day the press release is issued. (People always seem to find out about these things ahead of time).

      Besides, didn't you say the FDA had already made their announcement????????? You know, the one you did not want to say where it was and no one else could find???????

      Sentiment: Strong Buy

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