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Ann: FDA Supports Accelerated Approval Pathway for Heart Failure, page-493

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  1. 5,499 Posts.
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    Agree, LVAD AA is the one to follow closely now .. HLHS is still in early stages, I'm probably overly optimistic that this will get breakthrough or RMAT, which would allow AA pathway .. its probably as you say, underfunded and will need a partner or funded by future operating cash flow. So likely a bit further out than I hoped.

    CLBP is underway and from memory it has interim analysis' built into the trial design, so an early stop could be on the cards mid next year.

    SR-aGVHD at best is another resubmission for pediatrics (if successful, will be first to market), but second best outcome is to get the adult trial up and running to definitely get an adequate and well controlled study to the FDA for this indication. If that were to eventuate, then its more likely that Rex / LVAD will get to market first, and heart partner will be signed (if not earlier). For those who have forgotten, we were gifted this at no cost .. and looking a lot more likely than ever before to get a chance to 'double dip' on a US partner for heart failure.
 
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