CytoSorbents Corporation (CTSO)

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Last April, we achieved FDA Breakthrough Designation of CytoSorb to remove ticagrelor during urgent or emergent cardiothoracic surgery. However, expectedly, the Agency focused on the pandemic which significantly delayed the FDA's availability to advance non-COVID-19 applications. That said, we recently just met again with the Agency and believe that we are now aligned on the positive benefit-risk profile of the therapy and the additional clinical data needed to support approval.
"That said, we recently just met again with the Agency"