Cell Therapy News/Articles, page-16567

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    The problem for MSB is that Dr Halabi had read the briefing materials and had made an affort to understand what was in the presentation and what Mesoblast had tried to gloss over from the trial and their interpretation. And it was pretty important. Almost half of the trial subjects were missing biomarker data which MSB were using to draw conclusions about how effective the treatment was and the in Vitro TNFR1 assay that was supposed to correlate well with survival didn't correlate with the in vivo markers of the supposed mechanism of action.

    So IMO Mesoblast had aa new idea for a better potency assay that they hoped would correlate with both survival and in Vivi responses and the MoA. The FDA said it seemed a "reasonable approach". Dr Rose however revealed that the new assay had run into trouble so they had gone back to the ?TNFR1.

    Lets see what the FDA make of it this time.
 
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