if we put potency data meetings aside for a moment and also the initiation of trials for adult gvhd and back pain..im wondering if the market is pricing anything in for outcomes of upcoming fda meetings regarding heart failure in adults and kids.
these meetings will be of great sigificance to potential partnership negotiations..
what does accelerated approval look like. what are other favourble outcomes? e.g. are we talking about surrogate endpoints for the next trial, kids and adults approved with 1 trial.
Ann: FDA Grants Rare Pediatric Disease Designation for Revascor, page-94
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