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Re: Doc logic post# 313504

Saturday, 10/03/2020 1:04:28 AM

Saturday, October 03, 2020 1:04:28 AM

Post# of 823584
They already have Orohan status and Rolling approval comes with RMAT. RMAT is the designation for RE division that approves this type of cell related treatment. It’s newer and better for this area and is not just FDA created, it was created by an act of Congress and the Office of the President. So it has a bigger, broader and more powerful mandate. It comes directly out of the 21st Century Cures Act that I mention frequently but seems to wiz over the conversations.
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