so now we know the very encouraging part of the fda meeting was about the prospects for aa in the sickest of the sick end stage hf with lvad (2500 cases per year in usa). and something about this meeting made them very excited about the upcoming paeditric hlhs meeting. (1000 cases per year usa)
so im thinking the next study will potentially serve the dual purpose of achieving accelerated approval through surrogate endpoints and then by extending the study to examine longer term clinical benefit it will also become the confirmatory trial for full approval. ??
so now we know the very encouraging part of the fda meeting was...
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