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InVivo Therapeutics Holdings Corp. Message Board

  • cynicoptimist cynicoptimist Jan 12, 2013 8:34 AM Flag

    F O R T Y F I V E

    My bad... And F&genbecker is right it is 45 days not 30 days as was suggested by someone else here. So... there may not be any announcement regarding this on Monday. Here is an excerpt from the FDA website:

    (b)FDA action. Within 45 days of receipt of a request for HUD designation, FDA will take one of the following actions:

    (1) Approve the request and notify the applicant that the device has been designated as a HUD based on the information submitted;

    (2) Return the request to the applicant pending further review upon submission of additional information. This action will ensue if the request is incomplete because it does not on its face contain all of the information required under 814.102(a). Upon receipt of this additional information, the review period may be extended up to 45 days; or..........

    Good to see that if there is any deficiency it can be extended another 45 days, though I hope it is solid the first time. So, we could get the answer some time in the next 2 weeks!

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    • Hi Cynic - I didn't know of the extra 45 days to fix it if something is wrong with the initial submission. Thanks for relaying this. I don't think it will be needed given the experienced team they have in dealing with the FDA, but one never knows and glad to see there is that extra timeframe versus going to the back of the line.

      You're right - we sh/get the answer sometime in the next 2 weeks!

      Sentiment: Strong Buy

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