BioCardia Inc (BCDA)

[realfast95]

FDA sticks it to VCEL. BCDA your stand-alone

VCEL PR
During the presentation the Company also announced that it had met with the U.S. Food and Drug Administration (FDA) on September 29, 2017 for a scheduled Type B meeting to discuss the potential for an accelerated approval pathway for ixmyelocel-T for the treatment of patients with advanced heart failure due to ischemic dilated cardiomyopathy (DCM) utilizing existing Phase 2 clinical trial data. Ixmyelocel-T has received orphan drug, fast track development and regenerative medicine advanced therapy designation from the FDA in this indication. The FDA indicated that the Company should plan to conduct at least one additional adequate and well-controlled clinical study to support a Biologics License Application for ixmyelocel-T. Consistent with its previously disclosed strategy to focus investments on its high-growth commercial business, the Company does not plan to conduct any additional clinical studies for ixmyelocel-T unless fully funded by a partner.