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InVivo Therapeutics Holdings Corp. Message Board

  • cynicoptimist cynicoptimist Jan 31, 2013 9:52 AM Flag

    It is still 45 days?

    Please see the following copy of a post by "msonyclaw" on ihub: I believe this info is correct.

    "Clarification on relevant time frames

    there is some apparent confusion as to the whether there is a 45 or 75 day response time from
    fda based on the dec 14, 12 filing of nviv.

    according to fde rules
    to obtain the hde (humanitarian device exemption approval) one must first file a designation request for a humanitarian use device (hud).
    PART 814 -- PREMARKET APPROVAL OF MEDICAL DEVICES
    Subpart H--Humanitarian Use Devices
    Sec. 814.102 Designation of HUD status.
    (a)Request for designation. Prior to submitting an HDE application, the applicant shall submit a request for HUD designation to FDA's Office of Orphan Products Development.

    on dec 14 nviv filed the request for designation as a hud, not the hde, since hde application is not allowed until the designation request is granted.

    the 45 day rule applies to the hud designation.

    according to the regs-the date can be extended if additional information is requested
    as stated in CFR 814.102(b)(2) then "Upon receipt of this additional information, the review period may be extended up to 45 days"; or the request can be denied.

    nviv claims it is engaged "in discussions with fda" concerning its request. if all of the required information was supplied upon the filing, then an approval should be issued within 45 days: Remember the dec 14,2012 press release stated fda response "expected in january, 2013", ie within the 45 days of december 14th, not 75 days from december 14, 2012.

    (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;

    Agency practice may vary from its written rules, but we have to assume that additional information was requested, if no approval has been received, and assuming no outright denial of the request.

    In that case, we would need to know the last date requested info was submitted to try and compute when the fda is expected to act.

    Apparently, nviv will not disclose any FDA requests since the filing of the designation request, so we are in a bit of quandary. If we have to wait until the final formal fda action is received by nviv, then we are just up in the air at this point. All or most of us would prefer to obtain a detailed update but that is not apparently the management style of this company. Maybe we have a baker who does not want to be disturbed until there is a finished cake. This is not a very comfortable position. Let's hope we get some positive clarifications or results soon."

    ONCE AGAIN... this is the predominant complaint from investors: Frank's communication style. It is just not fair to the investors to continuously over-promise and then not keep us informed. So it is not 75 days according to the FDA website. WHY HAVEN'T WE RECEIVED OUR UPDATE?

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    • This is 45 Calender days and it resets every time they have communication. Example Company submits HUD and FDA asks for more information the 45 day window starts over. Regarding 75 days this has nothing to do with the HUD. This is for the Marketing application and nothing to do with HUD submission. Marketing application and HUD submission are 2 difference offices in FDA. So sit back and have a little patience.

      NVIV could have a YES and not report it and send in the marketing application.

      Sentiment: Strong Buy

    • Hello cynic - GREAT post and thank you.

      I was getting more concerned about Frank not knowing the rules rather than blowing the horn too quickly.

      You have confirmed that he knows the rules, which is great to hear. I personally do not have a problem with his tooting the horn - most people on this board would never have heard of NVIV if it were not for Frank and his pr actions over the past couple of years.

      Sentiment: Strong Buy

      • 1 Reply to fagenbecker
      • Becker what are your thoughts - I used to say that I personally don't have a problem with Frank tooting his horn. Yes it is good for putting NVIV on people's radar. But, this is becoming a pattern and for current shareholders it really does affect over-all credibility.

        But are you also missing the point? You're correct. Frank knows the rules. So it isn't so much a matter of horn tooting as it is being responsible to the shareholders and keep us informed. We are past the deadline and his saying NOTHING is closer to the actions of a pinksheet scam than a responsible and up-coming company with great potential, which InVivo Therapeutics is. It is no wonder the price has dropped. A price drop is fine for buying more shares but the entire situation of how he communicates or doesn't communicate is entirely unacceptable.

 
NVIV
1.31+0.04(+3.15%)Nov 21 3:53 PMEST

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