yes quartery incoming. dont expect it to be too "hawkish"
something like this.
financials
-placement completed
-cash burn
-royalties on temcell.
operations
-orphan drug and rare disease designation for hlhs.
plan to meet fda to discuss possibility of the trial supporting accelerated approval.
-accelerated approval pathway supported for lvad.
plan to meet fda pre bla submission.
-gvhd data sufficient to refile. intend to refile current quarter.
-backpain trial underway.
banter and General Discussion, page-9517
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