Ann: Remestemcel-L for COVID-19 MIS-C published in Pediatrics, page-189

Agree, I am intrigued to see how MSB's discussion with the FDA about the heart trial. According to the FDA, secondary endpoints can only be interpreted IF the primary endpoint is met. The reason for this is because, as explained by the FDA document, the secondary endpoints is to support the outcome of the result. For example: If we see a reduction in tumour size as a primary endpoint, then the secondary endpoint might be more patients survived in the treated group.

MSB DREAM-HF trial has the same design, using a surrogate for efficiency rather than measuring death, stroke and heart attack itself - "the triple endpoint". HOWEVER, this design is logical only if the secondary outcome is explained/as a result of the primary outcome (or vice versa). This means that a reduction in hospitalisation will lead to a reduction in the triple endpoint. Our trial result refuted this 'hypothesis', which SI mentioned in his presentation, that hospitalization is NOT strongly associated with the triple endpoint. This was confirmed in numerous other HF trials, including Norvatis Parogon-HF trial that was "approved'' by FDA 2 days ago despite the trial FAILED its primary endpoint (p=0.06). These studies also show that many drugs can reduce hospitalization but not death. IF SI is able to show that hospitalization is not a surrogate for the triple endpoint then??? I don't want to speculate on what can or cannot happen. All I know is if Novartis was dealt MSB's cards, the outcome would be very positive.

https://www.novartis.com/news/media-releases/novartis-entresto-granted-expanded-indication-chronic-heart-failure-fda