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17:07
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Originally posted by Eternal:
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We may well find that the original Crohn's trial worked, but required such a high dose of cells that the pharmacoeconomics didn't make sense compared to highly profitable treatments like back pain. Dr Lightner's new trial uses a much lower number of cells delivered directly to the site rather than an IV infusion where the cells go through the lungs first, then through the rest of the body before reaching fistulae. The amount that can be charged for this disease is limited by a number of factors - but you wouldn't be able to charge anywhere near the dollar value of aGvHD which uses a similar number of cells in kids (ballpark figure). It would be silly to produce the high numbers of cells required for the original trial of Crohn's when there is an urgent demand in dying kids with aGvHD and where the cost of treatment can be justified at much higher dollar values.
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I agree however it is fairly obvious that those old trials had positive results. They did however have design faults. What would be interesting to see if they had also collected samples for biomarker data . I would exspect those trials would be the basis for the current trial and a future P3 would be a pivotal trial for full approval.
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