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Re: Gremlin3a post# 5865

Monday, 02/27/2017 4:26:03 AM

Monday, February 27, 2017 4:26:03 AM

Post# of 8023
Yes most definitely. The FDA will review the data and decide (1)whether it is safe and efficacy for Commercial BLA approval OR (2) need more trial data.

https://clinicaltrials.gov/ct2/show/NCT01670981?term=vericel+and+DCM&rank=1

This Phase 2 trial is a 114 persons 5 year 2012-2017 trial and is the same exactly to a Pivotal Phase2B from which the FDA has more than sufficient data to make the Commercial BLA decision. All of these 114 persons would normally be dead by now as all are

"Symptomatic heart failure in NYHA functional class III or IV"
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