HI ,In early 2020 COVID 19 emerged as a major threat to public...

HI ,In early 2020 COVID 19 emerged as a major threat to public health. The protocol for the trial was established in conjunction the FDA to provide rigorous statistical analysis, however, neither party had the benefit of a dose escalating phase 2 study to better define the patient group who may benefit from the therapy. In addition, the standard of care for ARDS patients changed during recruitment with the consequence that the statistical analysis was compromised. Nevertheless, we estimate there are 20 trial participants alive today who would otherwise have died from the virus but for remestemcel-L. Confirmatory trials are required, but the efficacy data is supportive of a significant benefit to COVID ARDS patients aged 65 and under. In any given year in the US influenza and pneumonia are responsible for thousands of deaths and in our view this will remain an attractive market for Novartis long after COVID disappears from headlines. According to its most recent update Novartis has no other drug candidates in development for ARDS. We believe there remains ample upside for Novartis if it chooses to proceed with already signed MSB Development Agreement.

BP.

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