Ann: Mesoblast Phase 3 Chronic Low Back Pain Results, page-154

Left-e, I'm putting your Yahoo chat in here as a post also, so the chat between you and London is visible:

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  Left-e1 hour ago

  Very encouraging CLBP results. Opioid sparing. Plan to meet with FDA to discuss accelerated pathway. CC now ongoing.

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  How are you feeling about MESO?

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    Left-e21 minutes ago

    @london, there are two aspects to the study. One aspect is pain reduction and an injection of rex-L gave a durable improvement in pain at 24 months across the entire 391 patient study. The second aspect is improved function, ie ability to move. There the benefit was statistically significant in the patients who received their injection before 68 months (ie 5 years 8 months) of symptoms. It was less significant in patients who had been suffering pain longer than that. So, pain improved in all patients, but ability to bend forward or perform physical activity was limited to those who received their injection earlier than 5 years 8 months after onset of pain.

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    London24 minutes ago

    Looks like it missed? But still strong p values

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    London45 minutes ago

    @Left-e Same, kinda of annoying that retail get the notice late, but all the analyst must have seen the results way beforehand as they had a heap of questions ready.
    
    The announcement though doesn't confirm whether endpoint was met? Although says results are statistically significant

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    Left-e53 minutes ago

    I joined CC late... it was very short notice and no PR, so I don't know exact results. They do plan to meet with FDA to discuss possible accelerated approval, so at least some of the results are good.

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    London58 minutes ago

    @Left-e Given no words where used around meeting primary endpoint, is that because they are still needing to review the results? Just reading now, but cannot see whether the primary was met or not

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    Left-e59 minutes ago

    "We're very excited by these results" - SI

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    Left-e59 minutes ago

    Planning to do a confirmatory study in Europe. Patients become a candidate for MPC injection after 6 months of conservative treatment. Five-year window for cell-based treatment.

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    Left-e1 hour ago

    Fielding questions from analysts. "There is a major opioid crisis in US. Opioid sparing activity demonstrated by product means a different approach in the US. Greatest opiod sparing effect seen with earlier intervention with MPC injection in this study."

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    Left-e1 hour ago

    "Grunenthal partnership for Europe in place. In discussions with other potential partners for US market or Mesoblast may go it alone"

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    Left-e1 hour ago

    p-values significant according to SI. "Very positive with respect to statistical analysis". "Well-conducted large randomized controlled trial that reproduces results of an earlier study." "Opioid sparing and durable pain reduction" - SI

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