Don’t want to jump ahead too much, but if the trial is...

Don’t want to jump ahead too much, but if the trial is successful... then the focus will be placed on manufacturing / product quality in my opinion.

If remestemcel-l is approved for COVID ARDs then SR-aGVHD then becomes a label extension (assuming we don’t get accelerated approval before then), and the FDA’s argument that Rux was approved for other indications prior to SR-aGVHD is somewhat weakened.

But on manufacturing... that is where Novartis will have a large role to play. There may need to be a multi arm trial with certain CQA’s knocked down in remestemcel-l to demonstrate MSB’s proposed mechanism of action take place in a randomised controlled trial setting... that requires larger trial populations sizes and a lot of funding to execute... something MSB can’t and won’t need to do on it’s own.