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Endo International plc Message Board

  • cobbob46 cobbob46 Oct 17, 2012 3:43 PM Flag

    Ipxl info on warning letter that is a non event. Great time to add growth at reasonable cost!

    From a high level source at Impax that clarified a warning letter that has held shares low. Company received warning letter for an oversight of updating a standard operating procedure.

    Company has since Replaced head of QC lab with highly experienced professional from Watson. The previous individual did not update the standard operating procedure by the FDA, hence the company replaced that person with an experienced Watson person to solve the issue.

    ‒ Company has modified the procedures and re-trained the chemists prior to FDA inspector leaving the facility

    ‒ They have completed most of the retrospective data review of products on the market to make sure there is no quality issues

    ‒ No significant issues identified at this point

    ‒ No field action or recalls as a result of the retrospective data review of products to date

    I am certain this was a non event that has punished the company's stock. As they wait for a reinspection that will happen at the impulse of the FDA, the Rytary decision put off until January was a positive event for the company to resolve the non-event that has been an anchor for the company's stock.

    It is my firm opinion that once this issue is resolved we will see a 15-25% rise in the shares pre the Rytary launch. In any event Impax is selling at a major discount to its peers for a non material event and deserves immediate recognition.

 
ENDP
70.10+1.46(+2.13%)10:21 AMEDT

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