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JPL1868

04/10/17 11:19 AM

#49736 RE: 0mn1 #49731

We get that. But it's RMAT approval from the FDA so people use it interchangeably.

NoMoDo

04/10/17 11:26 AM

#49752 RE: 0mn1 #49731

RMAT is approved by the FDA. RMAT has at it's option to grant conditional approval and then required results to be submitted over the following 6 months WHILE they are marketing their product. As long as the product is safe and they even minimally show an improvement, they keep their approved status.