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I've been reviewing the EMA's guidelines document that PAR...

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    I've been reviewing the EMA's guidelines document that PAR mention in reference to a TGA provisional application.
    Something they seem big on is JSN, Joint space narrowing, specifically as measured by X-Ray.

    https://hotcopper.com.au/data/attachments/5180/5180168-687d79bac22bbfcc5ddf13c0ed2a94f5.jpg

    PAR mention as the only segment they review by x-ray.

    https://hotcopper.com.au/data/attachments/5180/5180171-949625352f1f8a696892e7217ffa5b18.jpg

    They don't however directly attribute any of the results to Joint space width or narrowing, there's mention of MRI a lot but not of X-Ray results.

    I'm assuming where they're talking about improvements in cartilage loss, this is perhaps analogous to JSN?

    https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-clinical-investigation-medicinal-products-used-treatment-osteoarthritis_en.pdf
 
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