PTD unknown


  1. 225 Posts.
    Just wondering where the info came that there is an inquiry into rheumatoid arthritis by the FDA. It is not on there web-site. The "Australian" states that this is the reason for the drop yesterday.

    The latest labeling of Remicade states:

    Patients with long duration of Crohn’s disease or rheumatoid arthritis and chronic exposure to
    immunosuppressant therapies are more prone to develop lymphomas (see ADVERSE REACTIONS,
    Malignancies/Lymphoproliferative Disease). The impact of treatment with REMICADE on these phenomena is

    Thus, it is acknowledged that the disease that is being treated is more likely to be associated with lymphoma. As the drug is being used in the most serious cases of the disease, it is highly likely that more people being treated in an non-placebo matched environment - that is following its release after completion of phase 3 trials - are going to get lymphoma, because of the nature of their disease, not necessarily the drug.

    So, does anybody really know if there really is an FDA inquiry or is it all just vicious rumour, and that yesterday was just a sell off by AMP.

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