Hi @reginaldp & @Treed, there's quite a load of high-level...

Hi @reginaldp & @Treed,

there's quite a load of high-level research material indicating what should be widely seen an acceptable role for IL-6 as a diagnostic biomarker but (importantly, IMO) also as a prognostic biomarker for sepsis i.e. indicating the likely progression of the disorder in the absence of treatment or intervention. See, for example this linked article. FDA's position generally on sepsis, I'm not sure about.

But, in any case, the announcement by MSB that, on treatment, ischemic rexlemestrocel-l trial participants experienced IL-6 levels returning to normal by 2 months and remaining low through 12 months can only get the FDA's attention and reasonable support on the benefit side of the risk-benefit assessment on an AA determination. This might be part of the fine detail on mortality in the FDA's recent feedback.

I understood from the announcement of March 11, 2024 that the FDA may have communicated/ indicated to Mesoblast that it was accepting that, in the LVAD trial, ischemic controls were characterized by persistently elevated levels of IL-6, as an inflammatory cytokine. Link here. 'Characterisation' (or characterization) is more than 50% of the predictive game that the FDA is so fond of i.e. predictive of treatment outcomes.

So, without reading too much into the (properly) limited disclosure in the announcement, I'd say it's game on.

All good stuff, IMO.

Cheers
GLTA(LT)H