Presentation on ASX Gems Conference on 21st June, page-156

Silviu - transcript -

Most advanced form of the disease where the patients had a ventricular assist device implant. We were able to significantly improve or increase the proportion of patients who could be successfully have their device turned off. And that was associated with an 82% reduction in mortality. On that basis, the FDA felt that this together with a supportive data from the largest study over 30 months, we also saw reduction in mortality and the three point mass reduction had together. We were eligible to apply for an accelerated approval without any further clinical data. And as I mentioned earlier, we will be requesting a prebuilt a meeting second half of this year to talk about timing for our accelerated approval in the most severe group of patients.



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