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InVivo Therapeutics Holdings Corp. Message Board

  • cynicoptimist cynicoptimist Apr 4, 2013 10:08 AM Flag

    No Caution! IDE **is** the green light to human clinicals, and we **may** have that as well

    Fact: They have the HUD. Why is a HUD issued? (Think about that one)
    Fact: Over 30 days on the IDE and so far no rejection.
    Fact: Some have posted direct wording from the FDA website saying if no answer in 30 days = approved.
    Someone needs to ask the company about the IDE. If this is a dual approval, the human trials can begin. This should surge past $4 once this is confirmed.

    Sentiment: Buy

    SortNewest  |  Oldest  |  Most Replied Expand all replies
    • I'm guessing IDE not very far behind. It may require some additional notes, restrictions, instructions etc from the FDA to Invivo that requires more time to finish up on the FDA side, but most likely it's being processed in a positive manner imo, do your own dd and gl. Maybe Invivo has taken the first steps towards curing paralysis.

      Sentiment: Strong Buy

    • I wouldn't say "caution" per say, but there are companies out there that have had orphan status approval without approval to begin trials. IDE approval was dependant on HUD, but HUD is not dependent on IDE so we can have one without the other.

      Disclosure: I'm hopeful that we'll see a PR in the morning for IDE approval. Once obtained the milestones I'm looking for are:
      - Trial start and positive results, or at minimum, proof of safety
      - Removal of warrents (or warrents excercised), hiring of a CFO, and uplisting to the NASDAQ
      - Institutional buying
      - 501(k) partnerships this year to solidify cash position

      • 1 Reply to onsite84
      • I won't disagree, 84, but what the F good is an HUD without an IDE? I will guess the examples you are aware of are in the pharma world and might involve a potentially harmful drug. In the case of InVivo's bio-scaffold device, I think it is more likely that the HUD approval telegraphs an imminent IDE approval.

        Sentiment: Strong Buy

    • You are too logical-LOL. I cannot find any reason to allow a HUD without allowing an IDE. We should hear by the end of tomorrow at the latest.

      Sentiment: Buy

 
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