Ann: COVID ARDS Trial Topline 60-Day Results, page-60

In short, remestemcel-l has demonstrated in a randomised controlled study that it works - albeit in patients under 65.

Silvui eluded to a confirmatory study, but only after going through all the data thoroughly (top-line data only just received by MSB) and having yet another interesting discussion with the FDA.

Novartis now has the data along with Mesoblast who will spend the next few weeks analysing it all. But reduction in mortality in under 65 patients, especially those treated with dex have pretty much sealed the deal IMO. I've seen large pharma partner up on phase 1 or even pre-clinical data... here Novartis have a peak under the hood with an RCT that effectively gives them a major de-risk and confidence in how to set up the ARDS trial.

Novartis announcement expected in the next few weeks... if that goes ahead, and if they get a good outcome from an FDA meeting which is also due sometime this quarter...

Goodluck all