Ann: IND QUESTIONS RECEIVED FROM US FDA, page-388

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easysell

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01/07/21

18:14

Post #: 54218351
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Originally posted by adherent: ↑

I've just had my post-treatment consultation with my doctor, and I said upthread I would check on sourcing and other things and report back.

So I have just completed a 6 week course of 2x/wk injections iPPS. My OA back pain has essentially fully resolved and I am back into upping my training volume. An excellent result which both my doctor and myself are very pleased with.

I confirmed that my prescription was for off-label Elmiron, ground up and compounded into an injectable formulation.

Given that my next course might be in 9-12 months, my doctor said that PAR may have TGA approval by then and he might be in a position to prescribe on label Zilosul. Obviously he is hoping that would be the case.

He's treated quite a few sportspeople for knee arthritis, but I was his first patient with a spinal presentation so he was quite interested in my outcome, demonstrating as it does efficacy in that situation. My OA is highly localised to a specific facet joint. He mentioned I might make a useful case study and I'd love it if that were the case. Always interested in finding out more about myself.

I raised my concerns about deadlifting, squats etc. where the spine is under compression and therefore load bearing bone on bone. He told me about a guy with knee OA and bone marrow lesions for whom PPS resolved the BML, and further, demonstrated hypertrophy of the bone surface. In other words, while cartilage was not restored, the bone structure adapted in some way to compensate to a degree. I thought that was interesting.

Also had a discussion about intranasal and even oral delivery. He said he had had reports of people seeing a response to oral Elimiron (not in his practice), although he would not be recommending it. We had the discussion about intranasal, but we both agreed there was reason to be concerned about bioavailability, and since I have no issue with self injecting and that is clearly the superior route that we would continue on that path.

Hope that's interesting,
cheers,
adherent

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Hi @adherent, thanks for sharing your positive experience and results.
Like a few here I have knee OA however due to my line of work and location I'm unable to commit to the trials or SAS. I would greatly like to discuss your treatment and experience further but think its best taken offline. Please contact me at [email protected]
Much appreciated.

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Ann: IND QUESTIONS RECEIVED FROM US FDA, page-388

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Ann: IND QUESTIONS RECEIVED FROM US FDA, page-388

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