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Ann: 36-Month Results of Phase 3 Trial in Chronic Low Back Pain, page-157

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Sorepocket

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12/01/22

17:36

Post #: 58812816
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Originally posted by ChickenCrimpy: ↑

IMO, this is a nothing point and we are making mountains out of molehills and potentially going around and around in circles, wavering between suggesting MSB have gone their own way (to whatever degree they have or at all) relative to whatever FDA have suggested/advised/otherwise, and whether they should also have included an arm of baseline plus HA.

There is a gap in knowledge here, but I will put the below here from the phase 2 trial (https://www.mesoblast.com/clinical-trial-results/mpc-06-id-phase-2):

At 12 months, a responder analysis showed that there was clear separation between both treatment groups and both control groups at every decile increase in response beyond the MICD of 30% reduction in pain from baseline. In line with guidance from KOLs and from payers, a responder analysis was performed targeting at least 50% reduction in pain from baseline. At both 6 and 12 months, a reduction in pain from baseline of 50% or more, without any additional intervention, was seen in 59.3% of the MPC-06-ID group, 44.8% of the 18 million MPC group, 18.8% of the saline group, and 15.8% of the HA group, as measured by visual analog scale, or VAS (p = 0.006 across all four groups, p=0.023 for 6 million MPC against saline and p=0.006 against HA). Statistical significance denotes the mathematical likelihood that the results observed are real and not due to chance.

Not unreasonable to assume that the demonstrated benefit of the cells over HA was the reason they didn't waste time and money having another arm in the phase 3 trial, but at the end of the MSB and possibly the FDA would know this as the underlying reason why.

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Thanks for the bolding my old chook. Always good to know which ones are the important words.

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Ann: 36-Month Results of Phase 3 Trial in Chronic Low Back Pain, page-157

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Ann: 36-Month Results of Phase 3 Trial in Chronic Low Back Pain, page-157

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