Heart failure is a very serious condition and undeniably meets the criterion of "unmet medical need".
I am of the view that the FDA is very eager to let stem cell therapies address this need even if they are not the most optimal in efficacy, but do show safety. The need is dire.
Case in point:
Back in April 2016, Vericel's ixmyelocel‑T product failed to meet it's secondary endpoints of heart-pumping efficiency and six-minute walking distance in the Phase 2b trial.
You read that right - it FAILED to meet it's secondary endpoints. And that was in the Phase 2b trial.
Yet, on 02/21/2017, the FDA designated the investigation of ixmyelocel‑T for reduction in the risk of death and cardiovascular hospitalization in patients with chronic advanced heart failure due to ischemic dilated cardiomyopathy as a Fast Track Development Program.
So, chill, y'all.
Heart failure is a very serious condition and undeniably meets...
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