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Wright Medical Group N.V. Message Board

  • cjcollins17 cjcollins17 Aug 9, 2013 12:51 PM Flag

    Injectable Trials?"?

    I've not really been following other areas of Augment in some months. This nonApproval is a realy Drainer... Drained any of my profits out of WMGI.
    I'm hoping for a quick Appeal and some information from Management....Listening to that CC replay didnt give me anything.

    Where are we on the Augment Injectable trials. Saw the info that Uni posted.

    If Appeal is denied, then I only see the Injectables as getting anything out of the CRV...but how long on that front.


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    • cj, I spoke with IR today and basically the injectable trials remain in limbo until this regular Augment PMA gets decided on. They reiterated no decision has been made regarding appeal, new trial, etc... I like you got hammered on paper today on the CRV's but I think they can come back to somewhat close to where they were should Wright appeal decision or at the very least work with the FDA on new trials to confirm Augments value and usefullness. They were going to have to run post approval studies anyway so perhaps they can 'negotiate' with the FDA that the next trial needs only i.e. 100 or 150 patients not the 300+ in prior trial. That will save time and money and be a good comprimise.

      I read through the agreement and non-approval was not a basis for not paying the CRVs but rather denial:
      "d) On the Approval Milestone Payment Date, the Company shall pay to the Trustee, by wire transfer to the account designated by the Trustee on the date hereof, an amount equal to the product of (i) the Approval Milestone Payment multiplied by (ii) the number of Securities Outstanding, and the Trustee shall promptly (but in any event within two (2) Business Days) pay to each Holder of record of the Securities as of the close of business in New York City, three (3) Business Days prior to the Approval Milestone Payment Date (the “ Approval Record Date ”), an amount equal to the product of (i) the Approval Milestone Payment multiplied by (ii) the number of Securities held by such Holder as of the Approval Record Date. Notwithstanding the foregoing, in no event shall the Company be required to pay the Approval Milestone Payment more than once, and the Company shall not be required to pay the Approval Milestone Payment if: (i) the FDA issue an order under 21 CFR 814.45 denying FDA Approval of Augment; or (ii) the Approval Milestone occurs after the Termination Date. For the avoidance of doubt, FDA Approval of anything other than the AUGMENT PMA shall not trigger the Approval..."

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