CHF Accelerated Approval !, page-101

@LearningEachDay. Nice find. This draft guidance from the FDA also bodes well for the MAGIC biomarkers/algorithm use for Rem-L in GvHD to predict the natural disease progression often leading to death for the paediatric SR-aGvHD patients with multiple organs affected (especially gut and liver). This algorithm based on significant real world data and IMO considered an adequate control group external to the trial (where a placebo group within our trial was deemed unethical because there were no other approved therapies available for use in children 12 years and under with this horrible disease). Nice to know the FDA is also now considering Real World Data in the body of evidence to support label extensions. I am sure this will greatly benefit us further down the track post approvals as we gather more real world data from Japan and especially if off-label use increases in US presumably for diseases sharing dangerous uncontrolled inflammation (e.g. ARDS and sepsis). We are already uncovering a link between how our cells are extremely helpful for gut symptomology across diseases involving the gut such as more severe GvHD and Crohns. In good time I am sure we will stumble across many more. In the meantime, I am just patiently awaiting our first approval in the US (or SI announcing the bombshell that FDA will look at a single trial submission for ischemic/diabetic CHF).