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Ann: PARADIGM RECEIVES FEEDBACK FROM US FDA ON IND SUBMISSION, page-289

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    Sorry Hamman, but the report is not indicating that she doesn't have OA, actually, it is indicating the opposite. Marked (therefore significant) OA changes are present including significant thinning of the medial (inside) meniscus and associated tearing/fissuring. Some changes in lateral (outside) meniscus and a 5mm osteophyte (spur) is present. All are signs of fairly advanced OA in the knee.

    "No bony lesion is identified" is a comment in relation to no observable tumours (benign or malignant), bony cysts, or possibly infective changes to the periosteum (therefore outer surface of the bone).

    No comment has been by the radiologist regarding the presence or absence of subchondral bone marrow eodema, which is what Paradigm has claimed has reduced with iPPS treatment.

    This report alone does not indicate that iPPS has been beneficial in reducing or slowing down OA changes in the knee. This assumption can only be arrived at if previous and current MRI scans are compared and there has been no indication by the reporting radiologist that this has been attempted. I'd love to be able to view any previous and current MRI's of the knee if they exist and am happy to comment on them if you wish.

    Your wife having a significant decrease in pain and improved function is also awesome and indicates that iPPS works for pain relief and improved function.
    If an MRI is performed in 2-3 years and looks fairly similar or better that would be great and indicates DMOAD.
 
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