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Celldex Therapeutics, Inc. Message Board

  • whippersnapper65 whippersnapper65 May 19, 2013 5:09 PM Flag

    Might CLDX delay disclosing breakthrough treatment status?

    According to the FDA's own protocol, that agency will not disclose when breakthrough status has been granted to a treatment. That decision is left to the company.

    Might it be the case that CLDX would delay announcing the granting of breakthrough status, if it were received, for either Rindo or 011 as part of a strategy for negotiating a partnership? I don't think CLDX would be required to report immediately, as a material event, that it was granted breakthrough status for one or more of its treatments, but it could disclose that fact to potential partners who have signed non-disclosure agreements with CLDX. Then, in conjunction with announcing a partnership agreement CLDX could announce the breakthrough treatment designation(s) that had been granted.

    The information below is from the FDA website, Q&A about breakthrough treatment status:

    10) Will the FDA announce when a drug has been granted breakthrough therapy designation?
    FDA will not disclose information regarding sponsors who submitted requests for or who have been granted or denied breakthrough therapy designation. Breakthrough therapy designation requests are typically submitted to an IND, and the FDA cannot disclose the existence of an IND, or any submissions that have been submitted to the IND, unless it has previously been publicly disclosed or acknowledged per 21 CFR 312.130(a).

    Sentiment: Strong Buy

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    • That sounds impossible because that is pertinent news that would have to be disclosed to shareholders. Just as fast track approval or anything that affects company/shareholders. ?

      • 1 Reply to neshua10
      • Do SEC regulations require that any material event or item be disclosed within a specified time frame, or do the regulations only require that when a material event or item is disclosed that it is disclosed through public channels so that no favored group of investors gains an advantage by being granted privileged information? I believe it is the latter. In addition, of course, insider trading with knowledge of non-disclosed material events or items is prohibited.

        If I am right that a material event or item does not have to be disclosed within a specified timeframe, then CLDX could be sitting on information that it has not yet disclosed.

        Sentiment: Strong Buy

    • Management has been playing possum for a few months. I think something big could happen soon.

      Sentiment: Strong Buy

    • As a follow-up, the FDA makes its decisions regarding breakthrough status very quickly: within 60 days. The table information below did not preserve its formatting, but if you go to the FDA website with the FAQ about breakthrough treatment status, the very first question/response on the page has the table in easily readable format.

      I bet CLDX submitted its applications for Rindo and 011 in 1Q of 2013. The results for 011 will have a bearing on how the phase-iii trial is designed.

      Breakthrough Requests-CDER & CBER Jul 9, 2012 – Sep 31, 2012 Oct 1, 2012 – Dec 31, 2012 Jan 1, 2013-Mar 31, 2013
      Requests for BT Designation Received

      CDER = 2
      CBER = 0

      CDER = 13
      CBER = 1

      CDER = 20
      CBER = 4
      Combined Quarterly Total Received

      2

      14

      24
      Requests for BT Designation Granted

      CDER = 0
      CBER = 0

      CDER = 2
      CBER = 0

      CDER = 8
      CBER = 0
      Combined Quarterly Total Granted

      0

      2

      8
      Requests for BT Designation Denied

      CDER = 0
      CBER = 0

      CDER = 3
      CBER = 0

      CDER = 7
      CBER = 2
      Combined Quarterly Total Denied

      0

      3

      9
      Percent where action was taken within 60 days of receipt of the request


      100%


      100%


      100%

      Note: Table last updated March 31, 2013, and includes requests received but pending a decision at the time of update. Designation will be noted in the quarter in which action was taken, even if the request was received in a previous quarter. This table will be updated quarterly.

      Sentiment: Strong Buy

 
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