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InVivo Therapeutics Holdings Corp. Message Board

  • fagenbecker fagenbecker Jan 17, 2013 2:11 PM Flag

    Does anyone know?

    Question - does anyone know if the FDA releases their 'rulings' on a particular day of the week, or do they come at random?

    Sometimes a Fed agency does their 'announcements' or 'rulings' on a particular day of the week on a weekly basis; wondering if this is the case with the FDA?

    Thanks ahead of time.

    Sentiment: Strong Buy

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    • I believe this "approval to start a trial" could come at any time. It's not preset like a FDA panel review of a drug trial or actual FDA decision on a drug. Items like NCE or Orange book updates happen middle of month (tomorrow) but imo this could be announced at any time. all imo, i could be wrong on this??

      Sentiment: Strong Buy

      • 1 Reply to alabamatigers11u
      • Adding to that, NVIV may not announce it the same day. So even if they approve it today, they may not PR it until early next week.

        And just a reminder to all, the Orphan status approval is due from the FDA by end of January, but approval to start the trials is different, and could come at any time. While also expected sometime soon, if we don't hear anything by the end of January, that doesn't mean they won't approve it in a few days/weeks/months after that.

        There exists the risk that the FDA will deny it, but as a current shareholder, I hope that the company has had enough correspondence with the FDA to alleviate any concerns they might have.

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