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Re: north40000 post# 6490

Tuesday, 09/19/2017 5:33:24 PM

Tuesday, September 19, 2017 5:33:24 PM

Post# of 8022
Am not an expert but I think VCEL's approach is different. From the last CC by the CEO:

"ixmyelocel-T is among the first products to receive the RMAT designation and to our knowledge the first product to receive a RMAT designation for the treatment of a serious cardiovascular disease. The designation highlights both the significance of the results from the Phase 2b XL DCM clinical study and the unmet medical needs for improved therapies to treat patients with advanced heart failure due to ischemic DCM. We now have orphan disease, fast track and RMAT designations for ixmyelocel-T and we continue to execute on our stated strategy of pursuing expedited approval pathways and partnering opportunities for the program."
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