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