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Aegerion Pharmaceuticals, Inc. (AEGR) Message Board

  • moneynow27 moneynow27 Nov 11, 2013 7:32 AM Flag

    The FDA warning letter is very serious....

    All AEGR investors/traders should read the entire FDA warning letter. Yahoo won't let me link it here, but if you go to the Seeking Alpha website, key in AEGR in your search, you'll see a few paragraphs on the matter, and then the last bullet has the link to the actual letter.

    For those who may think it's a non-event, I'm afraid you're mistaken; this is a very serious letter: Below is a key paragraph in the letter:

    Conclusion and Requested Action
    "For the reasons discussed above, your statements provide evidence that Juxtapid is intended
    for new uses, for which it lacks approval and for which its labeling does not provide adequate
    directions for use, which renders Juxtapid misbranded within the meaning of the FD&C Act
    and makes its distribution violative of the FD&C Act. See 21 U.S.C. 352(f)(1), 331(a); 21
    CFR 201.5, 201.100, 201.115, 201.128."
    "OPDP requests that Aegerion immediately cease misbranding Juxtapid and introducing it into
    interstate commerce for unapproved uses for which it lacks adequate directions. Please
    submit a written response to this letter on or before November 22, 2013, stating whether you intend to comply with this request, listing any promotional materials (with the 2253
    submission date) for Juxtapid that contain statements such as those described above, and
    explaining your plan for discontinuing use of such materials or, in the alternative, your plan to
    cease distribution of Juxtapid. Because the violations described above are serious, we
    request, further, that your submission include a comprehensive plan of action to disseminate
    truthful, non-misleading, and complete corrective messages about the issues discussed in this letter to correct any misimpressions about the approved use of Juxtapid."

    Investors have to be able to trust the CEO of a company. If that trust is violated, you wonder what else is going on behind the scenes. At the very least, I would expect an 8K from the company very soon.

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