Basically the DSMB has called a halt to enrolment in the trial due to a lack of efficacy. So patients already treated will be followed up and the analysis completed. Then SI can do some more post hoc analysis to try and find something hopeful he can sell to investors as a reaon the trial shouldn't be considered a failure. There isn't any way in the wide world the FDA are going to consider granting approval for this indication based on these results. It's seems a very long shot that Novartis won't pull the plug on the deal. IMO the FDA is still going to want a proper RCT for aGvHD, and a further trial for heart failure if SI still wants to pursue it. I think investors need to consider their exposure to the company very carefully.
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Basically the DSMB has called a halt to enrolment in the trial...
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